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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/20/26 has been entered.
Response to Amendment
The amendment filed 05/20/26 has been entered. Claims 1 have been amended. Claims 2-6 and 8-10 are in the original/ previously presented form. Claim 7 is cancelled. Claim 11 is newly presented. Thus, claims 1-6 and 8-11 remain pending in the application. There were no objections or 112 rejections previously set forth in the Final Office Action mailed 02/25/26. Therefore, there are no objections or 112 rejections withstanding.
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 1-6 and 8-11 are rejected under 35 U.S.C. 103 as being unpatentable over Oda (U.S. PGPUB No. 2013/0237951).
Regarding claim 1, Oda discloses an injector (see Fig. 1a) for injecting a solution that contains biomolecules (see [0018-0019]) into an injection target (see [0013-0015]) from an injector main body (2, see [0049]) without performing injection through a given structure in a state where the given structure is inserted into the injection target (see [0002] & [0017]: injector is needleless), the injector (see Fig. 1a) comprising:
an accommodation unit (area of 7/14/8 containing injection solution ML, see [0054]) configured to accommodate a solution that contains biomolecules (see [0018-0019] & [0054]: enclosing unit has injection objective substance that may contain vaccine/protein/etc., which are biomolecules);
a piston (6, see [0054]);
a nozzle unit (5) including an injection port (4) configured to inject the solution being pressurized into an injection target at an injection start time (Oms) (see [0055]); and
a driving unit (20 & 9, see [0058]) comprising an igniter (see [0049-0051]) configured to combust an ignition charge (22, see FIG. 2) and a gas generating agent (30) arranged to generate gas by combustion (see [0052-0054] & [0058]) and to apply pressure to the piston (see [0058]: “the gas generating agent 30 arranged in the combustion chamber 9 so that the pressure is applied to the injection solution ML enclosed in the through-hole 14 by the aid of the piston 6”), the gas generating agent (30) having a predetermined dimension, size, or shape (see [0053]: “it is possible to change the combustion completion time of the gas generating agent 30 by adjusting the dimension, the size, and/or the shape, especially the surface shape of the gas generating agent 30 when the gas generating agent, 30 is arranged in the combustion chamber 9.” Thus, the dimension, size, shape used is predetermined),
wherein a combustion completion time of the gas generating agent is defined by the predetermined dimension, size, or shape (see [0037] & [0053]: “it is possible to change the combustion completion time of the gas generating agent 30 by adjusting the dimension, the size, and/or the shape, especially the surface shape of the gas generating agent 30 when the gas generating agent, 30 is arranged in the combustion chamber 9.”), wherein a transition of pressure applied to the solution via the piston is determined by the combustion completion time (see [0037]: pressure determined by completion time and completion time controllable via design parameters such as size/dimension/shape of combustion agent), such that, upon combustion of the ignition charge (see [0058]: combustion generates gas to move piston):
an injection speed of the solution is maintained (see [0037] & [0069-0070]: speed of injection obtained by pressure, see pressure such as shown for L1 in FIG. 4 and described in [0066-0068]) during a time period (see L1 in Fig. 4) between a first time (left of the leftward time bound of Δt, see ‘Modified FIG. 4’ below)
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from the injection start time (injection start time at 0 in FIG. 4) and a second time from the injection start time (time corresponding to P2max1),
the injection speed generally increases during the time period (from leftward bound of Δt to the time corresponding to P2max1) while the injection speed is maintained (pressure maintained above Pw1 throughout injection) throughout the time period (from leftward bound of Δt to the time corresponding to P2max1), the time period (from leftward bound of Δt to the time corresponding to P2max1) comprising at least one sub-period (see ‘Modified FIG. 4’ above), and
the injection speed decreases first (pressure==speed is at P1max at leftward bound of Δt and immediately decreases to Pw1) and then increases in the at least one sub-period (slightly after rightward bound of Δt, see ‘Modified FIG. 4’ above, pressure==speed increases in the sub-period) while the injection speed is maintained throughout the time period (pressure==speed always above P1max),
wherein the time period comprises an initial time period (see ‘Modified FIG. 4’ above) from the injection start time, and a remaining time period (see ‘Modified FIG. 4’ above) from the injection start time,
wherein the injection speed increases during the initial period (pressure==speed increasing up to P1max, see Fig. 4 and [0066-0068]), and
wherein the injection speed has a curved profile during the remaining time period (see curved profile in ‘Modified FIG. 4’ above) as defined by the transition of pressure produced by combustion of the gas generating agent (see [0077-0080], with further explanation in [0068-0076]),
the injection speed comprising a maximum injection speed (P2max1) that is highest in an entirety of the time period (as shown in FIG. 4), the maximum injection speed occurring in the remaining time period (see ‘Modified FIG. 4’ above).
Oda is silent to the exact (see italicized text below) maintained speed and the milliseconds for the time periods such as:
an injection speed of the solution is 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 generally increases during the time period while the injection speed is maintained “to be at 40 m/s or more” throughout the time period
the injection speed decreases first and then increases in the at least one sub-period while the injection speed is maintained “at 40 m/s or more” throughout the time period
wherein the time period comprises 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, Oda teaches that changing the injection pressure will change the injection speed (see at least the equation in [0037], [0053], [0069-0070] and [0077-0080]). Therefore, a person of ordinary skill in the art would consider injection speed to be a result effect variable that is optimized through routine experimentation of changing/modifying the injection pressure to obtain a desired injection speed, such as 40m/s or more.
Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the injection speed by modifying the injection pressure (for example, by manipulating variables in the equation of [0069-0070] like diameter of nozzle and/or by manipulating the combustion mode/ completion time/etc. by way of the igniter and gas generating agent, see [0037], [0053], and [0068]) to obtain a maintained injection speed of 40m/s or more during the time period (corresponding to the maintained pressure above Pw1 as shown in FIG. 4) 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), thus achieving:
an injection speed of the solution is maintained “at 40 m/s or more” during a time period between a first time from the injection start time and a second time of from the injection start time.
the injection speed generally increases during the time period while the injection speed is maintained “to be at 40 m/s or more” throughout the time period, and
the injection speed decreases first and then increases in the at least one sub-period while the injection speed is maintained “at 40 m/s or more” throughout the time period.
Next, Oda teaches that changing the size, dimension, or shape of the gas generating agent will change the combustion completion time and subsequently the pressure profile, including the time required to reach certain pressure values (see at least the equation in [0037], [0053], [0066-0080]). Therefore, a person of ordinary skill in the art would consider the time required to reach certain pressure values to be a result effect variable that is optimized through routine experimentation of changing/modifying the combustion completion time to obtain a desired injection pressure, within a desired 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 time required to reach certain pressures by modifying the combustion completion time (for example, by manipulating the combustion mode/ completion time/etc. by way of the igniter and gas generating agent, see [0037], [0053], and [0068]) to obtain a maintained injection speed of 40m/s or more during a specific time period, such as “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 and wherein the time period comprises 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 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), thus achieving:
an injection speed of the solution is 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
wherein the time period comprises 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.
Regarding claim 2, the modified system of Oda teaches the injector according to claim 1, and Oda further discloses wherein the nozzle unit (5, see Fig. 1a) is configured to inject the solution into the injection target (see [0055] and [0059-0080]]) such that the injection speed of the solution is a minimum amount or more during the time period (see time period in ‘Modified FIG. 4’ above. The injection minimum pressure of Pw1 is maintained and would have a corresponding minimum injection speed).
Oda is silent to the injection speed minimum being “such that the injection speed of the solution is 75 m/s or more during the time period.”
However, Oda teaches that changing the injection pressure will change the injection speed (see at least the equation in [0037], [0053], [0069-0070] and [0077-0080]). Therefore, a person of ordinary skill in the art would consider injection speed to be a result effect variable that is optimized through routine experimentation of changing/modifying the injection pressure to obtain a desired injection speed, such as 75m/s or more.
Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the injection speed by modifying the injection pressure (for example, by manipulating variables in the equation of [0069-0070] like diameter of nozzle and/or by manipulating the combustion mode/ completion time/etc. by way of the igniter and gas generating agent, see [0037], [0053], and [0068]) to obtain an injection speed of 75m/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), thus achieving the injection speed minimum being “such that the injection speed of the solution is 75 m/s or more during the time period.”
Regarding claim 3, the modified system of Oda teaches the injector according to claim 1, and Oda further discloses wherein the nozzle unit (5, see Fig. 1a) is configured to inject the solution into the injection target (see [0055] and [0059-0080]]) such that an injection speed of the solution is achieved (see FIG. 4) is 75 m/s or more between the first time and a third time (time right before peak P1max) 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 (pressure==speed increasing up to P1max, see Fig. 4 and [0066-0068]).
Oda is silent to the exact (see italicized text below) maintained speed and the milliseconds for the time period such that wherein the nozzle unit is configured to inject the solution into the injection target such that an injection speed of the solution is achieved “is 75 m/s or more” between the first time and a third time “of 0.15 ms” from the injection start time.
However, Oda teaches that changing the injection pressure will change the injection speed (see at least the equation in [0037], [0053], [0069-0070] and [0077-0080]). Therefore, a person of ordinary skill in the art would consider injection speed to be a result effect variable that is optimized through routine experimentation of changing/modifying the injection pressure to obtain a desired injection speed, such as 75m/s or more.
Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the injection speed by modifying the injection pressure (for example, by manipulating variables in the equation of [0069-0070] like diameter of nozzle and/or by manipulating the combustion mode/ completion time/etc. by way of the igniter and gas generating agent, see [0037], [0053], and [0068]) to obtain an injection speed of 75m/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), thus achieving the injection speed minimum being wherein the nozzle unit is configured to inject the solution into the injection target such that an injection speed of the solution is achieved “is 75 m/s or more” between the first time and a third time.
Next, Oda teaches that changing the size, dimension, or shape of the gas generating agent will change the combustion completion time and subsequently the pressure profile, including the time required to reach certain pressure values (see at least the equation in [0037], [0053], [0066-0080]). Therefore, a person of ordinary skill in the art would consider the time required to reach certain pressure values to be a result effect variable that is optimized through routine experimentation of changing/modifying the combustion completion time to obtain a desired injection pressure, within a desired 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 time required to reach certain pressures by modifying the combustion completion time (for example, by manipulating the combustion mode/ completion time/etc. by way of the igniter and gas generating agent, see [0037], [0053], and [0068]) to obtain a maintained injection speed of 75m/s or more during a specific time period, such as between a first time and a third time of “0.15 ms” from the injection start time 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), thus achieving wherein the nozzle unit is configured to inject the solution into the injection target such that an injection speed of the solution is achieved is 75 m/s or more between the first time and a third time “of 0.15 ms” from the injection start time.
Regarding claim 4, Oda discloses a method of injecting a solution that contains biomolecules into a cell nucleus of an injection target using the injector according to claim 1 (see [0072]: injection into epidermis and depth adjusted by first pressurizing mode, aligning with Applicant disclosure in at least [0033]: injection into cell nucleus is an injection that penetrates the epidermis at the claimed speeds. Therefore Modified Oda teaching claim 1 injects into a cell nucleus in as much as is described by Applicant), the method comprising: pressurizing the solution (see [0002-0003], [0016-0018]); and injecting the pressurized solution into the injection target (see [0055-0058]) such that the injection speed of the solution is maintained to be at an amount during the time period (see [0037] & [0069-0070]: speed of injection obtained by pressure, see pressure such as shown for L1 in FIG. 4 and described in [0066-0068]).
Oda is silent to the injection speed of the solution is maintained to be at “40m/s or more” during the time period.
However, Oda teaches that changing the injection pressure will change the injection speed (see at least the equation in [0037], [0053], [0069-0070] and [0077-0080]). Therefore, a person of ordinary skill in the art would consider injection speed to be a result effect variable that is optimized through routine experimentation of changing/modifying the injection pressure to obtain a desired injection speed, such as 40m/s or more.
Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the injection speed by modifying the injection pressure (for example, by manipulating variables in the equation of [0069-0070] like diameter of nozzle and/or by manipulating the combustion mode/ completion time/etc. by way of the igniter and gas generating agent, see [0037], [0053], and [0068]) to obtain a maintained injection speed of 40m/s or more during the time period (corresponding to the maintained pressure above Pw1 as shown in FIG. 4) 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), thus achieving the injection speed of the solution is maintained to be at “40m/s or more” during the time period.
Regarding claim 5, the modified system of Oda teaches the injector according to claim 1, and Oda further discloses wherein the nozzle unit (5, see Fig. 1a) is configured to inject the solution (see [0055] and [0059-0080]]) such that the injection speed of the solution is between a minimum amount and a maximum amount during the time period (see time period in ‘Modified FIG. 4’ above. The injection minimum pressure of Pw1 is maintained and would have a corresponding minimum injection speed. The peak or maximum pressure is shown as P2max1 for L1).
Oda is silent to the injection speed “is in the range of 40 m/s and 141 m/s” during the time period.
However, Oda teaches that changing the injection pressure will change the injection speed (see at least the equation in [0037], [0053], [0069-0070] and [0077-0080]). Therefore, a person of ordinary skill in the art would consider injection speed to be a result effect variable that is optimized through routine experimentation of changing/modifying the injection pressure to obtain a desired injection speed, such as in the range of 40 m/s and 141 m/s.
Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the injection speed by modifying the injection pressure (for example, by manipulating variables in the equation of [0069-0070] like diameter of nozzle and/or by manipulating the combustion mode/ completion time/etc. by way of the igniter and gas generating agent, see [0037], [0053], and [0068]) to obtain an injection speed in the range of 40 m/s and 141 m/s 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), thus achieving the injection speed “is in the range of 40 m/s and 141 m/s” during the time period.
Regarding claim 6, the modified system of Oda teaches the injector according to claim 1, and Oda further discloses wherein the at least one sub-period (see ‘Modified FIG. 4’ above) comprises two or more sub-periods different from each other (see ‘Modified FIG. 4i’ below),
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and wherein the injection speed (see [0037] & [0069-0070]: speed of injection obtained by pressure, see pressure such as shown for L1 in FIG. 4 and described in [0066-0068]) is configured to decrease first and then increase in each of the two or more sub-periods (see each sub-period shown above in ‘Modified FIG. 4i’ above. Each sub period decreases to the first coordinate indicated and then increases to the second coordinate, as indicated by the arrows shown in ‘Modified FIG. 4i’ above.).
Regarding claim 8, the modified system of Oda teaches the injector according to claim 1, and Oda further discloses wherein the injection speed of the solution comprises a minimum injection speed (injection minimum pressure of Pw1 is maintained and would have a proportional minimum injection speed according to [0037] & [0069-0070].) and the maximum injection speed (The peak or maximum pressure is shown as P2max1 for L1) during the time period, and wherein the maximum injection speed (P2max1 is above 40MPa and would have an injection speed proportional thereto as in [0037] & [0069-0070]) is more than 3 times of the minimum injection speed during the time period (91max shown around 12MPa. 3*12=36 and therefore p2max1 is more than 3 times the minimum).
Oda is silent to the max being “less than” 3 times the minimum injection speed.
However, Oda teaches that changing the injection pressure will change the injection speed (see at least the equation in [0037], [0053], [0069-0070] and [0077-0080]). Therefore, a person of ordinary skill in the art would consider injection speed to be a result effect variable that is optimized through routine experimentation of changing/modifying the injection pressure to obtain a desired injection speed, such as a maximum that “is less than” 3 times the minimum injection speed.
Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the injection speed by modifying the injection pressure (for example, by manipulating variables in the equation of [0069-0070] like diameter of nozzle and/or by manipulating the combustion mode/ completion time/etc. by way of the igniter and gas generating agent, see [0037], [0053], and [0068]) to obtain a maximum injection speed that “is less than” 3 times the minimum injection speed 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), thus achieving the max being “less than” 3 times the minimum injection speed.
Regarding claim 9, the modified system of Oda teaches the injector according to claim 1, and Oda further discloses wherein the injection target is cells in a living body (see [0027]: injection into farm animal or dog, aligning with Applicant’s disclosure of “living body” being a mammal in at least [0021] of the current Application), and wherein the driving unit (20 & 9, see [0058]) is further configured to control the piston (see [0058]) and cause the solution containing biomolecules to penetrate through an epidermis of the living body such that the solution containing biomolecules is directly injected into a cell nucleus of the cells in the living body (see [0072]: injection into epidermis and depth adjusted by first pressurizing mode, aligning with Applicant disclosure in at least [0033]: injection into cell nucleus is an injection that penetrates the epidermis at the claimed speeds. Therefore Modified Oda teaching claim 1 injects into a cell nucleus in as much as is described by Applicant) with high efficiency due to: the injection speed (see [0037] & [0069-0070]: speed of injection obtained by pressure, see pressure such as shown for L1 in FIG. 4 and described in [0066-0068]) maintained during the entirety of the time period (from P1max to after P2max1 as shown in ‘Modified FIG. 4’ above), the injection speed generally continuously increasing during the initial time period (pressure and speed increasing throughout initial time period after initial drop between pressurization modes and thus “generally” continuously increases. See [0066-0068]), the injection speed having a curved profile during the remaining time period (see curvature of L1 in FIG. 4), and the maximum injection speed (P2max1) occurring in the remaining time period (as shown in ‘Modified FIG. 4’ above).
Oda is silent to the maintained injection speed being “40 m/s or more” and the remaining time period curved profile being “such that the injection speed increases and decreases a plurality of times during the remaining time period”.
However, Oda teaches that changing the injection pressure will change the injection speed (see at least the equation in [0037], [0053], [0069-0070] and [0077-0080]). Therefore, a person of ordinary skill in the art would consider injection speed to be a result effect variable that is optimized through routine experimentation of changing/modifying the injection pressure to obtain a desired injection speed, such as 40m/s or more or a plurality of increases and decreases within a 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 speed by modifying the injection pressure (for example, by manipulating variables in the equation of [0069-0070] like diameter of nozzle and/or by manipulating the combustion mode/ completion time/etc. by way of the igniter and gas generating agent, see [0037], [0053], and [0068]) to obtain a maintained injection speed of 40m/s or more during the time period (corresponding to the maintained pressure above Pw1 as shown in FIG. 4) or a plurality of increases or decreases 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), thus achieving the maintained injection speed being “40 m/s or more” and the remaining time period curved profile being “such that the injection speed increases and decreases a plurality of times during the remaining time period”.
Regarding claim 10, the modified system of Oda teaches the injector according to claim 1, and Oda further discloses wherein the driving unit (20 & 9, see [0058]) controls the piston (see [0058]) such that: the injection speed generally continuously increases during the initial period (pressure and speed increasing throughout initial time period after initial drop between pressurization modes and thus “generally” continuously increases. See [0066-0068]), and the injection speed has a curved profile during the remaining time period (see curvature of L1 in FIG. 4).
Oda is silent to “and the injection speed increases and decreases a plurality of times during the remaining time period.”
However, Oda teaches that changing the injection pressure will change the injection speed (see at least the equation in [0037], [0053], [0069-0070] and [0077-0080]). Therefore, a person of ordinary skill in the art would consider injection speed to be a result effect variable that is optimized through routine experimentation of changing/modifying the injection pressure to obtain a desired injection speed, such as a plurality of increases and decreases within a 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 speed by modifying the injection pressure (for example, by manipulating variables in the equation of [0069-0070] like diameter of nozzle and/or by manipulating the combustion mode/ completion time/etc. by way of the igniter and gas generating agent, see [0037], [0053], and [0068]) to obtain a plurality of increases or decreases 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), thus achieving “and the injection speed increases and decreases a plurality of times during the remaining time period.”
Regarding claim 11, the modified system of Oda teaches the injector according to claim 1, and Oda further discloses wherein combustion of the gas generating agent generates a driving pressure that moves the piston (see [0052-0054] & [0058]: combustion generates gas to move piston), and the injection speed profile is defined by the combustion-driven movement of the piston (see [0015], [0022], [0037], [0058], [0069-0070], and [0077]: speed of injection obtained by pressure moving piston).
Response to Arguments
Applicant’s arguments with respect to claims 1-6 and 8-11 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
A new rejection under Oda has been applied to the claims, rendering the arguments against the individual previous references and/or a combination of the previous references moot.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHLEEN PAIGE VOKES whose telephone number is (571)272-0198. The examiner can normally be reached M-F: 730AM-330PM Eastern Time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHLEEN PAIGE VOKES/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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