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
The amendment filed 12/11/25 has been entered. Claim 1 has been amended. Claims 2-9 are in the original/ previously presented form. Claim 10 is newly presented. Thus, claims 1-10 remain pending in the application. There were no objections or 112b rejections previously set forth in the Non-Final Office Action mailed 10/01/25. Therefore, there are no objections or 112 rejections withstanding.
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.
(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, 5-6, and 8-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hunter et al. (U.S. PGPUB No. 2010/0016827), hereinafter Hunter.
Regarding claim 1, Hunter discloses an injector (see FIG. 9) for injecting a solution that contains biomolecules into an injection target (see [0002], [0009], [0070-0072]: injector delivers at high speed to penetrate skin, aligning with Applicant disclosure in at least [0033]: injection into injection target through the epidermis==skin) from an injector main body (900) without performing injection through a given structure in a state where the given structure is inserted into the injection target (see [0016], [0018], and [0054]: device is needle-free), the injector comprising:
an accommodation unit (950) configured to accommodate a solution that contains biomolecules (see [0087-0088]: drug reservoir easily replaceable medical vial containing a medicament);
a piston (920, see [0081]: any suitable piston);
a nozzle unit (910) including an injection port (see [0086]: an orifice that drug is injected out of) configured to inject the solution being pressurized into an injection target at an injection start time (Oms) (see [0086]: device injects drug out of orifice); and
a driving unit (965, see [0091]: a controller that controls motor 242) adapted to control (adapted to is functional language. Therefore, the driving unit only needs to be capable of performing the following recited claim limitations.) the piston (920) to adjust a transition of a pressure (see [0031-0032], [0052-0055], and [0061-0067]: voice coil motor delivers a controlled pressure vs time profile of the system) applied to the solution containing biomolecules via the piston (see [0053] & [0071-0072]: force/ pressure transferred to the piston) and cause:
an injection speed of the solution (see [0053-0054]: velocity directly related to pressure of system by equation in [0053]) to be maintained at 40 m/s or more during a time period between a first time of 0.006 ms from the injection start time and a second time of 0.20 ms from the injection start time (This clause follows the functional language of the “driving unit adapted to…”.
Hunter discloses that the pressure is controllable by the drive unit--see at least [0052-0055].
Hunter discloses that velocity is directly related to the pressure-- see at least [0053].
Hunter discloses that the system controller manages real time adjustments—see at least [0059] & [0072].
Hunter discloses the controller can be designed with custom injection profiles for different situations—see [0102-0104] & [0106].
Hunter discloses that the system delivers 10-60MPa over a few milliseconds—see [0002]—which is shown in FIG. 6 to equate to over 100m/s. Therefore, the system achieves and maintains speeds over 40m/s. See also FIG. 5 showing Pressure over time.
Lastly, Hunter discloses that every millisecond is programmable and is only limited by the processor capabilities—see [0092].
Therefore, because Hunter discloses that the controller obtains any velocity (by designing the pressure profile), the pressure/velocity profile is designable by the user, and the controller and system are capable of achieving the claimed speeds and millisecond controllability, the system is “adapted to” cause an injection speed of the solution to be maintained at 40 m/s or more during a time period between a first time of 0.006 ms from the injection start time and a second time of 0.20 ms from the injection start time),
the injection speed to generally increase during the time period while the injection speed is maintained to be at 40 m/s or more throughout the time period, the time period comprising at least one sub-period (see explanation in the clause above. This clause also follows the functional language of the “driving unit adapted to…”. Again, because Hunter discloses a system capable of achieving a velocity of at least 40m/s—see [0002], a processor capable of designing the injection profile by the millisecond—see [0092], and the injection profile designable by the user to fit any need—see [0102-0104] & [0106], Hunter meets the claim limitation of the driving unit “adapted to” cause the injection speed to generally increase during the time period while the injection speed is maintained to be at 40 m/s or more throughout the time period, the time period comprising at least one sub-period), and
the injection speed to decrease first and then increase in the at least one sub-period while the injection speed is maintained to be at 40 m/s or more throughout the time period (see explanation in the previous clauses above. This clause also follows the functional language of the “driving unit adapted to…”. Therefore, Hunter meets the claim limitation of the driving unit “adapted to” cause the injection speed to decrease first and then increase in the at least one sub-period while the injection speed is maintained to be at 40 m/s or more throughout the time period),
the time period comprising an initial time period between 0.006 ms and 0.050 ms from the injection start time, and a remaining time period between 0.050 ms and 0.20 ms from the injection start time (see explanation in the previous clauses above. This clause also follows the functional language of the “driving unit adapted to…”. Therefore, Hunter meets the claim limitation of the driving unit “adapted to” cause the time period comprising an initial time period between 0.006 ms and 0.050 ms from the injection start time, and a remaining time period between 0.050 ms and 0.20 ms from the injection start time),
the driving unit (965, see [0091]: a controller that controls motor 242) further adapted to (adapted to is functional language. Therefore, the driving unit only needs to be capable of performing the following recited claim limitations):
control the piston (see [0053] & [0071-0072]: force/ pressure from the driving unit is transferred to the piston. Therefore, the driving unit is configured to control the piston) such that the injection speed generally continuously increases during the initial period (see explanation in the previous clauses above. This clause also follows the functional language of the “driving unit adapted to…”. Therefore, Hunter meets the claim limitation of the driving unit “adapted to” cause the injection speed to generally continuously increase during the initial period), and
control the piston (see [0053] & [0071-0072]: force/ pressure from the driving unit is transferred to the piston. Therefore, the driving unit is configured to control the piston) such that the injection speed has a curved profile during the remaining time period, and the injection speed increases and decreases a plurality of times during the remaining time period (see explanation in the previous clauses above. This clause also follows the functional language of the “driving unit adapted to…”. Therefore, Hunter meets the claim limitation of the driving unit “adapted to” cause the injection speed to have a curved profile during the remaining time period such that the injection speed increases and decreases a plurality of times during the remaining time period),
the injection speed comprising a maximum injection speed that is highest in an entirety of the time period, the maximum injection speed occurring in the remaining time period (see explanation in the previous clauses above. This clause also follows the functional language of the “driving unit adapted to…”. Therefore, Hunter meets the claim limitation of the driving unit “adapted to” cause the injection speed comprising a maximum injection speed that is highest in an entirety of the time period, the maximum injection speed occurring in the remaining time period).
Regarding claim 2, Hunter discloses the injector according to claim 1, and Hunter further discloses wherein the nozzle unit (910, see FIG. 9 and [0086]) is configured to (configured to is functional language. Therefore, the nozzle unit only needs to be capable of performing the following recited claim elements) inject the solution into the injection target such that the injection speed of the solution is 75 m/s or more during the time period (see Fig. 5: The device maintains about 20MPa pressure over 40ms. See Fig. 6: 20 MPa is about 200m/s. Therefore, the nozzle unit MUST BE “configured to” inject the solution with an injection speed of 75m/s or more during the time period in order to obtain the system results in FIG. 5 and 6. See also [0054-0055]: pressures measured before exiting nozzle and are therefore representative of nozzle capabilities).
Regarding claim 3, Hunter discloses the injector according to claim 1, and Hunter further discloses wherein the nozzle unit (910, see FIG. 9 and [0086]) is configured to (configured to is functional language. Therefore, the nozzle unit only needs to be capable of performing the following recited claim elements) inject the solution into the injection target such that the injection speed of the solution is 75 m/s or more (see Fig. 5: The device maintains about 20MPa pressure over 40ms. See Fig. 6: 20 MPa is about 200m/s. Therefore, the nozzle unit MUST BE “configured to” inject the solution with an injection speed of 75m/s or more in order to obtain the system results in FIG. 5 and 6. See also [0054-0055]: pressures measured before exiting nozzle and are therefore representative of nozzle capabilities) between the first time and a third time of 0.15 ms from the injection start time, and wherein the injection speed is configured to generally increase from the first time to the third time (the driving unit is configured to obtain the injection speed and times as claimed—see explanation in at least claim 1 above. The nozzle unit must be configured to deliver disclosed speeds and times in order for device to work; therefore, the nozzle unit MUST BE configured to deliver the disclosed speeds and times as well. see also [0071]: nozzle must be proper diameter and therefore the nozzle diameter could be “configured” to obtain any speed/profile by the designed system).
Regarding claim 5, Hunter discloses the injector according to claim 1, and Hunter further discloses wherein the nozzle unit (910, see FIG. 9 and [0086]) is configured to (configured to is functional language. Therefore, the nozzle unit only needs to be capable of performing the following recited claim elements) inject the solution such that the injection speed of the solution is in the range of 40 m/s and 141 m/s during the time period (see Fig. 5: The device has a pressure between at least 5MPa and 20MPa. See Fig. 6: 5-20MPa is in a range of about 90-200m/s. Therefore, the nozzle unit MUST BE “configured to” inject the solution with an injection speed in the range of 40 m/s and 141 m/s in order to obtain the system results in FIG. 5 and 6 which span the claimed range. See also [0054-0055]: pressures measured before exiting nozzle and are therefore representative of nozzle capabilities).
Regarding claim 6, Hunter discloses the injector according to claim 1, and Hunter further discloses wherein the at least one sub-period comprises two or more sub-periods different from each other (see explanations in the rejection of claim 1 above. The “at least one sub-period” language follows the functional language of the “driving unit adapted to…”. Therefore, “wherein the at least one sub-period comprises two or more sub-periods different from each other” also follows the functional language due to claim dependency. Again, because Hunter discloses a system achieving a velocity of at least 40m/s—see [0002], a processor capable of designing the injection profile by the millisecond—see [0092], and the injection profile designable by the user to fit any need—see [0102-0104] & [0106], Hunter meets the claim limitation of the driving unit “adapted to” cause the injection speed to generally increase during the time period while the injection speed is maintained to be at 40 m/s or more throughout the time period, the time period comprising at least one sub-period… wherein the at least one sub-period comprises two or more sub-periods different from each other), and wherein the injection speed is configured to decrease first and then increase in each of the two or more sub-periods (see further explanation in the rejection of claim 1 and the previous clause above. The injection speed “is configured to” is functional language. Therefore, Hunter meets the claim limitation of the driving unit “adapted to” decrease first and then increase in each of the two or more sub-periods).
Regarding claim 8, Hunter discloses the injector according to claim 1, and Hunter further discloses wherein the injection speed of the solution (this clause depends from claim 1 functional language: “a driving unit adapted to control… the piston… and cause an injection speed.” Therefore, Hunter meets the claimed limitations—see further explanation in claim 1 rejection above) comprises a minimum injection speed and the maximum injection speed during the time period, and wherein the maximum injection speed is less than 3 times of the minimum injection speed during the time period (Again, because Hunter discloses a system achieving a velocity of at least 40m/s—see [0002], a processor capable of designing the injection profile by the millisecond—see [0092], and the injection profile designable by the user to fit any need—see [0102-0104] & [0106], Hunter meets the claim limitation of the driving unit “adapted to” cause the injection speed, wherein the injection speed of the solution comprises a minimum injection speed and the maximum injection speed during the time period, and wherein the maximum injection speed is less than 3 times of the minimum injection speed during the time period).
Regarding claim 9, Hunter discloses the injector according to claim 1, and Hunter further discloses wherein the injection target is cells in a living body (see [0002], [0056], [0063], [0067], [0071], and [0095]: device delivers injection that penetrates skin==epidermis, aligning with Applicant disclosure in at least [0033]: injection into “cells” is an injection that penetrates the epidermis), and wherein the driving unit (965, see [0091]: a controller that controls motor 242) is further configured to (configured to is functional language. Therefore, the driving unit only needs to be capable of performing the following recited claim limitations.) control the piston (920, see [0031-0032], [0052-0055], and [0061-0067]: voice coil motor delivers a controlled pressure vs time profile of the system) and cause the solution containing biomolecules to penetrate through an epidermis of the living body (see [0002], [0056], [0063], [0067], [0071], and [0095]: device delivers injection that penetrates skin==epidermis) such that the solution containing biomolecules is directly injected into a cell nucleus of the cells in the living body with high efficiency (see Applicant [0034]: injection into cell nucleus dependent on injection speed. Therefore, Hunter discloses the drive unit “adapted to” control the piston… such that the solution containing biomolecules is directly injected into a cell nucleus of the cells in the living body with high efficiency—see further explanation in the rejection of claim 1 above or in the clauses below) due to:
the injection speed of 40 m/s or more maintained during the entirety of the time period (this clause follows the functional language above of the driving unit “configured to”. Again, because Hunter discloses a system achieving a velocity of at least 40m/s—see [0002], a processor capable of designing the injection profile by the millisecond—see [0092], and the injection profile designable by the user to fit any need—see [0102-0104] & [0106], Hunter meets the claim limitation of the driving unit “adapted to” cause the solution to penetrate the epidermis… due to “the injection speed of 40 m/s or more maintained during the entirety of the time period”),
the injection speed generally continuously increasing during the initial time period (this clause follows the functional language above of the driving unit “adapted to”. Therefore, Hunter meets the claim limitation of the driving unit “adapted to” cause the solution to penetrate the epidermis… due to “the injection speed generally continuously increasing during the initial time period”),
the injection speed having a curved profile during the remaining time period such that the injection speed increases and decreases a plurality of times during the remaining time period (this clause follows the functional language above of the driving unit “adapted to”. Therefore, Hunter meets the claim limitation of the driving unit “adapted to” cause the solution to penetrate the epidermis… due to “the injection speed having a curved profile during the remaining time period such that the injection speed increases and decreases a plurality of times during the remaining time period”), and
the maximum injection speed occurring in the remaining time period (this clause follows the functional language above of the driving unit “configured to”. Therefore, Hunter meets the claim limitation of the driving unit “configured to” cause the solution to penetrate the epidermis… due to “the maximum injection speed occurring in the remaining time period”).
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Coats et al. (U.S. PGPUB No. 2010/0016827), hereinafter Coats.
Regarding claim 1, Coats discloses an injector (100, see FIG.1) for injecting a solution that contains biomolecules into an injection target (see [0029]: injectate is a drug/vaccine/etc. vaccines would contain biomolecules) from an injector main body (104) without performing injection through a given structure in a state where the given structure is inserted into the injection target (see [0029]: needle free injection device), the injector (100) comprising:
an accommodation unit (106) configured to accommodate a solution that contains biomolecules (see [0029]: injectate in chamber 106);
a piston (120, see [0031] a plunger);
a nozzle unit (108) including an injection port (114, see [0029]: 114 is an opening in the nozzle) configured to inject the solution being pressurized into an injection target at an injection start time (Oms) (see [0029]: injectate delivered into target, such as skin, through 114); and
a driving unit (force generating mechanism 124 including motor 126, see [0031]) adapted to (adapted to is functional language. Therefore, the driving unit only needs to be capable of performing the following recited claim limitations.) control the piston to adjust a transition of a pressure applied to the solution containing biomolecules via the piston (see [0031]: 124/126 controllably apply force to piston to inject the injectate and [0030]: movement of plunger affects pressure of injectate within chamber 106. Therefore 124/126 adjust a transition of pressure applied to the solution when 124/126 apply a force to the piston) and cause:
an injection speed of the solution (see [0036]: application of input force on the plunger causes a target velocity and [0042-0043]: target velocity profile can be the velocity on the injection cycle) to be maintained at 40 m/s or more during a time period between a first time of 0.006 ms from the injection start time and a second time of 0.20 ms from the injection start time (see [0060-0061]: velocity profile can be designed by the user by modifying system parameters. Therefore, because Coats discloses that any velocity profile is obtainable by the system, Coats has a driving unit “adapted to” cause “an injection speed of the solution to be maintained at 40 m/s or more during a time period between a first time of 0.006 ms from the injection start time and a second time of 0.20 ms from the injection start time”),
the injection speed to generally increase during the time period while the injection speed is maintained to be at 40 m/s or more throughout the time period, the time period comprising at least one sub-period (see explanation in the clause above. This clause also follows the functional language of the “driving unit adapted to…”. Therefore, Coats meets the claim limitation of the driving unit “ adapted to” cause the injection speed to generally increase during the time period while the injection speed is maintained to be at 40 m/s or more throughout the time period, the time period comprising at least one sub-period), and
the injection speed to decrease first and then increase in the at least one sub-period while the injection speed is maintained to be at 40 m/s or more throughout the time period (see explanation in the clauses above. This clause also follows the functional language of the “driving unit adapted to…”. Therefore, Coats meets the claim limitation of the driving unit “ adapted to” cause the injection speed to decrease first and then increase in the at least one sub-period while the injection speed is maintained to be at 40 m/s or more throughout the time period),
the time period comprising an initial time period between 0.006 ms and 0.050 ms from the injection start time, and a remaining time period between 0.050 ms and 0.20 ms from the injection start time (see explanation in the clauses above. This clause also follows the functional language of the “driving unit adapted to…”. Therefore, Coats meets the claim limitation of the driving unit “ adapted to” cause the time period comprising an initial time period between 0.006 ms and 0.050 ms from the injection start time, and a remaining time period between 0.050 ms and 0.20 ms from the injection start time),
the driving unit (force generating mechanism 124 including motor 126, see [0031]) further adapted to (adapted to is functional language. Therefore, the driving unit only needs to be capable of performing the following recited claim limitations):
control the piston (see at least [0031]) such that the injection speed generally continuously increases during the initial period (see [0060-0061]: velocity profile can be designed by the user by modifying system parameters. Therefore, because Coats discloses that any velocity profile is obtainable by the system, Coats has a driving unit “adapted to” cause “the injection speed to generally continuously increase during the initial period”), and
control the piston (see at least [0031]) such that the injection speed has a curved profile during the remaining time period, and the injection speed increases and decreases a plurality of times during the remaining time period (see explanation in the clauses above. This clause also follows the functional language of the “driving unit adapted to…”. Therefore, Coats meets the claim limitation of the driving unit “adapted to” cause “the injection speed to have a curved profile during the remaining time period such that the injection speed increases and decreases a plurality of times during the remaining time period”),
the injection speed comprising a maximum injection speed that is highest in an entirety of the time period, the maximum injection speed occurring in the remaining time period (see explanation in the clauses above. This clause also follows the functional language of the “driving unit adapted to…”. Therefore, Coats meets the claim limitation of the driving unit “adapted to” cause “the injection speed comprising a maximum injection speed that is highest in an entirety of the time period, the maximum injection speed occurring in the remaining time period”).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 4 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Hunter (U.S. PGPUB No. 2010/0016827).
Regarding claim 4, Hunter discloses a method of injecting a solution that contains biomolecules into a cell nucleus of an injection target (see [0002], [0056], [0063], [0067], [0071], and [0095]: device delivers injection that penetrates skin==epidermis, aligning with Applicant disclosure in at least [0033]: injection into “cells” is an injection that penetrates the epidermis. Thus the device can reasonably be used in the application of injecting into a cell nucleus) using the injector according to claim 1 (see rejection of claim 1 above), the method comprising:
pressurizing the solution (see [0015] & [0100]: drug is pressurized); and
injecting the pressurized solution into the injection target (see [0071]: drug is injected into skin from nozzle of injector) such that the injection speed of the solution is maintained to be at 40 m/s or more (see FIG. 5 with over 15MPa delivered from 10-50ms, or a duration of 40ms. See FIG. 6 where 15MPa equates to over 150m/s. Therefore, the system delivers a speed over 40m/s for a time duration of 40ms).
Hunter (in the example represented by FIGs. 5 and 6) is silent to the method comprising injecting the pressurized solution such that the injection speed of the solution is maintained to be at 40m/s or more “during the time period.”
However, Hunter teaches that modifying the waveform of the controller will change the injection pressure profile (see [0102-0104]) and the millisecond sensitivity is only limited by the processor capabilities (see [0092]). Therefore, a person of ordinary skill in the art would consider the fraction of milliseconds of the time period that the system takes to reach and maintain the desired pressure/speed (see [0053]: pressure directly proportional to speed) to be a result effect variable that is optimized through routine experimentation of changing/modifying the waveform supplied by the selected controller with a processor of a desired sensitivity to obtain the injection speed at 40m/s or more “during the time period.”
Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the injection pressure profile disclosed in Hunter FIGs. 5 & 6 by modifying the waveform supplied by the controller to obtain the injection speed to be maintained at 40m/s or more “during the time period” as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 10, Hunter discloses the injector of claim 1, and Hunter further discloses wherein the driving unit (965 & 242, see FIG. 9 and [0091]: a controller 965 that controls motor 242) controls (see [0031-0032], [0052-0055], & [0061-0067]: voice coil motor delivers a controlled pressure vs time profile of the system and [0053] & [0071-0072]: pressure vs time profile of system transferred to the piston) the piston (920, see [0081]: any suitable piston) such that:
the injection speed (see pressure vs time in FIG. 5 and [0063] disclosing that pressure and velocity are related. Thus speed vs time figure would be proportional/scalable to pressure vs time profile such as by Bernoulli’s equation as described in [0053] &[0055] with the proportion shown in FIG.6) generally continuously increases during a period (see ‘Modified FIG. 5’ below),
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and the injection speed (see pressure vs time in FIG. 5 and [0063] disclosing that pressure and velocity are related. Thus speed vs time figure would be proportional/scalable to pressure vs time profile such as by Bernoulli’s equation as described in [0053] &[0055] with the proportion shown in FIG.6) has a curved profile (see curves of at least peaks and valleys as shown in FIG. 5), and the injection pressure(see FIG.5) increases (upward slopes such as those shown in ‘Modified FIG. 5’ above) and decreases (downward slopes such as those shown in ‘Modified FIG. 5’ above) a plurality of times (see multiple locations in ‘Modified FIG. 5’ above) during a second time period (see ‘Modified FIG.5’ above).
Hunter is silent to controls the piston such that the injection speed generally continuously increases during “the initial” period, the injection speed has a curved profile “during the remaining time period”, and the injection speed increases and decreases a plurality of times “during the remaining time period” because claim 1 defines the initial and remaining time periods as “an initial time period between 0.006 ms and 0.050 ms from the injection start time, and a remaining time period between 0.050 ms and 0.20 ms from the injection start time.”
However, Hunter teaches that modifying the waveform of the controller will change the injection pressure profile (see [0102-0104]) and the millisecond sensitivity is only limited by the processor capabilities (see [0092]). Therefore, a person of ordinary skill in the art would consider the fraction of milliseconds of the initial and remaining time periods that the system takes to reach and maintain the desired pressure/speed (see [0053]: pressure directly proportional to speed) to be a result effect variable that is optimized through routine experimentation of changing/modifying the waveform supplied by the selected controller with a processor of a desired sensitivity to obtain the injection speed generally continuously increases during “the initial” period, the injection speed has a curved profile “during the remaining time period”, and the injection speed increases and decreases a plurality of times “during the remaining time period.”
Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the injection pressure profile disclosed in Hunter FIGs. 5 & 6 by modifying the waveform supplied by the controller to obtain the injection speed generally continuously increases during “the initial” period, the injection speed has a curved profile “during the remaining time period”, and the injection speed increases and decreases a plurality of times “during the remaining time period” as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Coats as applied to claim 1 above, and further in view of Nagamatsu et al. (U.S. PGPUB No. 2018/0369484), hereinafter Nagamatsu.
Regarding claim 7, Coats discloses the injector of claim 1, and Coats further discloses wherein the driving unit (force generating mechanism 124 including motor 126, see [0031]) comprises a gas generating agent (see [0079]: compressed gas as a passive stored energy device can be released to, see [0085]: drive the injection), and wherein the driving unit is configured to change the transition of the pressure applied to the solution containing biomolecule to a desired transition (see [0031]: 124/126 controllably apply force to piston to inject the injectate and [0030]: movement of plunger affects pressure of injectate within chamber 106. Therefore 124/126 adjust a transition of pressure applied to the solution when 124/126 apply a force to the piston. Therefore, Coats meets the claim limitation of the driving unit is configured to “change the transition of the pressure applied to the solution containing biomolecule to a desired transition”).
Coats is silent to the driving unit “configured to generate a gas based on a combusted ignition charge” and the driving unit “is configured to change a combustion completion time of the gas generating agent… by adjusting at least one of a dimension, a size, or a shape of the gas generating agent”
However, Nagamatsu teaches an injector (1, see FIG. 1) for injecting a solution that contains biomolecules into an injection target from an injector main body (10) without performing injection through a given structure in a state where the given structure is inserted into the injection target (see [0045], [0099]: nozzle section 31 includes injection port 31a—both are needleless and see [0037-0038]: dosing liquid, such as DNA, RNA, etc.==biomolecules are injected into an object region, such as a tissue, organ, or cultured cells==injection target), the injector (1) comprising a driving unit (7, see [0054]: drive unit 7 sets fixing force of piston 5 and see [0063]: drive unit adjusts pressure transition of dosing liquid such as shown in FIG. 4A-B and described further in [0064]-[0067]), wherein the driving unit (7, see FIG. 1) comprises a gas generating agent configured to generate a gas based on a combusted ignition charge (see [0052]: gas generating agent generates gas when ignited/ combusted and gas generating agent included in drive unit 7 as necessary), and wherein the driving unit (7) is configured to change a combustion completion time of the gas generating agent, and change the transition of the pressure applied to the solution containing biomolecule to a desired transition by adjusting at least one of a dimension, a size, or a shape of the gas generating agent (see [0052]: combustion completion time and transition of pressure modified to desired value by adjusting size, shape, or surface profile of the gas generating agent).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the driving unit including a gas generating agent disclosed in Coats to be configured to generate a gas based on a combusted ignition charge as taught by Nagamatsu for the purpose of driving the drive unit by ignition charges (see [0050]) and obtaining a desired injection pressure transition of the dosing liquid according to the ignition charge (see [0052]), thus achieving the driving unit “configured to generate a gas based on a combusted ignition charge”.
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the driving unit configured to change the transition of the pressure applied to the solution containing biomolecule to a desired transition disclosed in Coats to be configured to reach the desired transition by changing a combustion completion time of the gas generating agent, and changing the transition of the pressure applied to the solution containing biomolecule to a desired transition by adjusting at least one of a dimension, a size, or a shape of the gas generating agent as taught by Nagamatsu for the purpose of driving the drive unit by ignition charges (see [0050]) and obtaining a desired injection pressure transition of the dosing liquid according to the ignition charge (see [0052]), thus achieving the driving unit “is configured to change a combustion completion time of the gas generating agent… by adjusting at least one of a dimension, a size, or a shape of the gas generating agent”.
Response to Arguments
Applicant's arguments filed 12/11/25 have been fully considered but they are not persuasive.
On page 6 of Applicant Remarks, Applicant submits that Hunter and Coats fail to disclose the functional limitations of claim 1 because the structure must be specifically designed, programmed, or arranged to perform the recited function. Thus, it appears that Applicant argues that because Hunter and Coats do not show a figure of the exact speed/pressure vs time profile as claimed, then Hunter and Coats are not “specifically designed, programmed, or arranged to perform the recited function.” However, the examiner disagrees because:
the disclosure of the prior art includes the drawings AND the specification and therefore the specification paragraphs cited from the prior art reference also serve as evidence related to the anticipatory rejection (see MPEP § 2131). Therefore, because Hunter and Coats both disclose in the specifications that the systems are designed to achieve any desired speed/pressure vs time profile (see evidence as set forth in the 35 U.S.C. §102 claim rejections under Hunter and, separately, Coats above), the examiner maintains that the systems are “DESIGNED” to perform the recited function
Hunter and Coats both disclose that the systems are designed to achieve any speed/pressure vs time profile and thus, the generic disclosures anticipate the claimed species because the species can be “at once envisaged” from the disclosures (see MPEP § 2131.02.III).
Therefore, the examiner was not persuaded by the argument and maintains that the 35 U.S.C. § 102 claim rejection of claim 1 under Hunter and the 35 U.S.C. § 102 claim rejection of claim 1 under Coats.
No further arguments were presented and therefore the examiner has also maintained all subsequent depending claim rejections.
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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/KATHLEEN PAIGE FARRELL/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783