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 July 14, 2026 has been entered. Claims 1-5 remain pending in the application. Applicant’s amendments to the specification, drawings, and claims have overcome the objections previously set forth in the Non-Final Office Action mailed April 15, 2026
Specification
The disclosure is objected to because of the following informalities: there appears to be a typo regarding “gas generating agent 30” as opposed to “gas generating agent 80” in paragraph [0130] of the PGPub, corresponding to paragraph [0068] of the specification as originally filed. Appropriate correction is required.
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.
Claims 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over Suzuki et al. (WO 2019004322 with citations from US 20200276392 - 371 of the PCT).
Regarding clam 1, Suzuki discloses a device assembly for a needleless injector (device assembly 10) configured to intradermally inject an injection objective substance (dosing liquid 320) without using an injection needle (“the present invention has an object to provide, to a needleless injector that injects a substance to be injected to a target region without using an injection needle” [0006]; “a substance for the treatment is preferably caused to reach a depth of the skin structure body in accordance with a purpose of the treatment. For example, the dendritic cell is present in the intradermal layer, and hence a more effective antigen-antibody reaction can be expected by causing vaccine to reach the layer.” [0061]), the device assembly comprising:
an enclosing unit (syringe portion 3) configured to enclose the injection objective substance (“The syringe portion 3 includes a nozzle portion 31 including the filling chamber 32 being a space capable of storing the injection solution.” [0039]);
a drive unit (sub-assembly 10B having drive portion 7) including an igniter (igniter 71) including an ignition agent and a gas generating agent disposed in a combustion chamber into which a combustion product generated by combustion of the ignition agent flows, the gas generating agent being configured to be ignited by the combustion product and thus to generate gas (“an igniter including an ignition charge and a gas generating agent that is disposed in a combustion chamber into which a combustion product generated by combustion of the ignition charge flows and that is combusted by the combustion product and generates predetermined gas.” [0017]);
a pressurizing unit (plunger 4 and piston 5) configured to pressurize, when the drive unit is driven, the injection objective substance enclosed in the enclosing unit (“a pressurizing portion configured to pressurize the substance to be injected encapsulated in the encapsulating portion” [0008]; “a user presses down the button 8 under a state in which the ejection port 31a is held in contact with the target region. With this, the injection solution 320 is pressurized via the piston 5 and the plunger 4, and ejection is performed.” [0056]); and
an ejection port (injection port 31a) through which the injection objective substance pressurized by the pressurizing unit is ejected to a target region (“the dosing liquid 320 having been pressurized to high pressure is injected to the outside from the injection port 31a of the flow path.” [0041]),
wherein the gas generating agent is formed in a manner that a combustion rate of the gas generating agent is lower than a combustion rate of the ignition agent (“the gas generating agent 80 is combusted at a lower combustion speed as compared to the ignition charge, and hence, even when combustion of the gas generating agent 80 is started, rise of the ejection pressure is relatively slow as compared to a process of reaching the first peak pressure.” [0058]), and a combustion duration of the gas generating agent (Figure 3, from first timing T1 to second timing T2) is longer than a combustion duration of the ignition agent (Figure 3, see all of [0058]),
wherein the pressurizing unit is configured to pressurize the injection objective substance in a manner that an ejection pressure of the injection objective substance increases to a first peak pressure after starting pressurization (first peak pressure P1), then decreases to a pressure lower than the first peak pressure (Figure 3), and then increases again to a second peak pressure (second peak pressure P2), the ejection pressure being defined as a pressure of the injection objective substance ejected from the ejection port (“the pressurizing portion pressurizes the substance to be injected having an ejection pressure defined as a pressure of the substance to be injected ejected through the ejection port. The ejection pressure is raised to a first peak pressure after pressurizing is started, is lowered to a pressure lower than the first peak pressure afterward, and then is raised to a second peak pressure again.” [0008], see also all of [0058] and Figure 3),
wherein the drive unit is configured to activate the igniter and cause the ejection pressure of the injection objective substance to reach the first peak pressure by a pressure of a combustion gas of the ignition agent, and configured to cause the ejection pressure of the injection objective substance to reach the second peak pressure by application of the pressure of the combustion gas of the gas generating agent to be combusted subsequently to the ignition agent (see all of [0056-0058]: “FIG. 3 shows transition of a pressure of the injection solution ejected through the ejection port 31a at the time of performing ejection of the injection solution by driving the drive portion 7 in the injector 1 (hereinafter, simply referred to as “ejection pressure”). [0057]; “first, the ignition charge in the igniter 71 is combusted, and then the gas generating agent 80 is combusted as described above…the first peak pressure P1 that forms sudden pressure transition at the initial stage of the ejection pressure transition emerges due to the ignition charge that is combusted at a relatively high combustion speed…When the ignition charge is combusted, the combustion product generated herein is exposed to the gas generating agent, and hence combustion of the gas generating agent 80 is started” [0058]),
wherein the ignition agent generates a combustion gas having a gas amount n1 (mol) and a temperature T1 (K) in combustion (“As characteristics of the above-mentioned ignition charge, the combustion product is gas at a high temperature but does not include a gas component at a room temperature, and hence the combustion product is condensed immediately after the ignition.” [0018], see all of [0050]), and
wherein the gas generating agent generates a combustion gas having a gas amount n2 (mol) and a temperature T2 (K) in combustion (“a gas generating agent that is disposed in a combustion chamber into which a combustion product generated by combustion of the ignition charge flows and that is combusted by the combustion product and generates predetermined gas.” [0017])
Suzuki fails to explicitly disclose the ignition agent generates a combustion gas defined in a manner that an energy value represented by n1 x T1 (mol∙K) in the combustion gas of the ignition agent is from 1.0 mol∙K to 2.5 mol∙K, and the gas generating agent generates a combustion gas defined in a manner that an energy value represented by n2 x T2 (mol∙K) in the combustion gas of the gas generating agent is from 6.1 mol∙K to 8.5 mol∙K.
However, Suzuki discloses that the amount of ignition agent and amount of gas generating agent, and therefore the amount of energy provided by their respective combustion gases, can be varied and optimized in order to adjust the ejection parameters for the needleless injector (see at least “the ejection parameters for the needleless injector such as the first peak pressure and the length between the peaks of the ejection pressure formed through pressurizing can be adjusted with parameters relating to combustion of the ignition charge and the gas generating agent, for example, through adjustment of an amount, a shape, an disposal relationship in the needleless injector, or the like of the ignition charge or the gas generating agent.” [0018], detailed throughout document). These ejection parameters can include the first and second peak pressures and the length of time between the peak pressures, which directly correlates to the injection depth (“the on-completion reached depth Df has a strong correlation with the first peak pressure P1, the second peak pressure P2, and the length between the peaks (T2−T1).” [0073]; “a kind, an amount, a shape, and the like of the ignition charge and the gas generating agent 80 mounted in the injector 1 are designed, and thus the transition of the ejection pressure of the injection solution from the injector 1, which achieves the desired on-completion reached depth Df, is achieved.” [0074]). Suzuki discloses and details three methods to vary and optimize these ejection parameters in order for the needleless injector to have the desired completion depth in paragraphs [0079-0097]. Suzuki discloses that the amount of ignition agent and amount of gas generating agent, and therefore the amount of energy provided by their respective combustion gases, are result-effective variables because adjusting the amount of ignition agent and gas generating agent (and therefore the amount of energy provided by their respective combustion gases) would result in an adjustment of the depth of the injection from the needleless injector (see at least [0074]). Additionally, Suzuki discloses a device assembly of a needleless injector for intradermal injection having the same claimed and disclosed structure and utilizing the same ignition agent and gas generating agent as claimed and disclosed in the present application. Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill int heart to modify the ignition agent and the gas generating agent of Suzuki such that the ignition agent generates a combustion gas defined in a manner that an energy value represented by n1 x T1 (mol∙K) in the combustion gas of the ignition agent is from 1.0 mol∙K to 2.5 mol∙K, and the gas generating agent generates a combustion gas defined in a manner that an energy value represented by n2 x T2 (mol∙K) in the combustion gas of the gas generating agent is from 6.1 mol∙K to 8.5 mol∙K because it has been held that discovering the optimum value of a result effective variable involves only routine skill in the art (MPEP 2144.05(II)). Based on the disclosure of Suzuki as detailed above, one having ordinary skill in the art would have a reasonable expectation of success and would recognize that it is known to vary and optimize the amount of ignition agent and amount of gas generating agent, and therefore the amount of energy provided by their respective combustion gases, in order to ensure that the needleless injector is able to deliver the injection objective substance to the target region at the desired depth (Suzuki [0061], [0085]).
Regarding claim 2, Suzuki discloses the device assembly for the needleless injector according to claim 1, wherein the ignition agent is any one of an explosive containing zirconium and potassium perchlorate, an explosive containing zirconium, tungsten, and potassium perchlorate, an explosive containing titanium hydride and potassium perchlorate, or an explosive containing titanium and potassium perchlorate, or an explosive containing a combination of a plurality of explosives among these explosives (“examples of the ignition charge include an explosive containing zirconium and potassium perchlorate (ZPP), an explosive containing titanium hydride and potassium perchlorate (THPP), an explosive containing titanium and potassium perchlorate (TiPP)…or an explosive composed of a combination of a plurality of these explosives.” [0050]).
Regarding claim 3, Suzuki discloses the device assembly for the needleless injector according to claim 1, wherein the gas generating agent comprises any one of a single-base gas generating agent, a double-base gas generating agent, or a triple-base gas generating agent each containing nitrocellulose, or a gas generating agent including a combination of a plurality of gas generating agents among these gas generating agents (“As one example of the gas generating agent, there may be exemplified a single base smokeless explosive formed of 98 mass % of nitrocellulose, 0.8 mass % of diphenylamine, and 1.2 mass % of potassium sulfate.” [0051]).
Regarding claim 4, Suzuki discloses a needleless injector comprising: the device assembly for the needleless injector (device assembly 10) according to claim 1; and a control unit (housing 2) to which the device assembly for the needleless injector is attached (“The device assembly 10 is freely attachable to and detachable from the housing 2.” [0038]), the control unit being configured to generate an activation signal for the igniter (“the housing 2 includes a battery 9 that supplies power to an igniter 71 included in the drive portion 7 of the device assembly 10. A user performs an operation of pressing down a button 8 provided to the housing 2, and thus the power supply from the battery 9 is performed between an electrode on the housing 2 side and an electrode on the drive portion 7 side of the device assembly 10 via a wired line.” [0038]).
Regarding claim 5, Suzuki discloses a method for injecting an injection objective substance, comprising: intradermally injecting an effective amount of the injection objective substance to a subject using the needleless injector according to claim 4 (“the injector 1 may be described as a device that forms the ejection pressure shown in FIG. 3 and pressurizes the injection solution. The injection solution to which such ejection pressure is applied physically acts on the target region, penetrates the surface of the target region, and enters the inside. Thus, injection of the injection solution to the target region is achieved. Herein, an example of the target region of the injector 1 includes a skin structure body of an organism of a human, a farm animal, or the like.” [0059]; “in a case where medical treatment or the like is performed with respect to the skin, a substance for the treatment is preferably caused to reach a depth of the skin structure body in accordance with a purpose of the treatment. For example, the dendritic cell is present in the intradermal layer, and hence a more effective antigen-antibody reaction can be expected by causing vaccine to reach the layer. Moreover, the chromocyte is present in the intradermal layer, and hence a predetermined substance for skin whitening is also required to be administered in the intradermal layer in a case where so-called beauty treatment for skin whitening is performed.” [0061]).
Response to Arguments
Applicant's arguments filed July 14, 2026 have been fully considered but they are not persuasive.
Regarding the argument that “the presented claimed device is not prima facie obvious in view of the teachings of Suzuki” (Remarks, page 7), the examiner respectfully disagrees.
The rejection does not rely on Suzuki explicitly disclosing the specific claimed ranges. Rather, the rejection relies on the fact that it would have been obvious to one having ordinary skill in the art to vary and optimize the amount of ignition agent and amount of gas generating agent, and therefore the amount of energy provided by their respective combustion gases because doing so would require only routine skill in the art through routine experimentation. The applicant presents the argument the data shown in Table 2 “demonstrates that there is a significant difference in effect (i.e. a criticality) between the inside and the outside of the numerical range specified in amended claim 1” (Remarks, page 7). However, such a “criticality” is not disclosed in the disclosure as currently presented, and the disclosure does not present the experimental results shown in Table 2 as being unexpected. Additionally, arguments by applicant cannot take the place of evidence on the record (MPEP 716.01(c)).
As detailed above, Suzuki discloses a device assembly for a needleless injector for intradermal injection having the same claimed and disclosed structure and utilizing the same ignition agent and gas generating agent as claimed and disclosed in the present application, except for claimed energy values of 1.0 mol∙K to 2.5 mol∙K and 6.1 mol∙K to 8.5 mol∙K. However, Suzuki discloses that the amount of ignition agent and amount of gas generating agent, and therefore the amount of energy provided by their respective combustion gases, are result-effective variables that are varied and optimized in order to adjust the ejection parameters for the needleless injector ([0018], detailed throughout disclosure with methods to vary and optimize in [0079-0097]), wherein the ejection parameters can include the first and second peak pressures and the length of time between the peak pressures, which directly correlates to the injection depth ([0073-0074]). One having ordinary skill in the art would have a reasonable expectation of success and would recognize that it is known to vary and optimize the amount of ignition agent and amount of gas generating agent, and therefore the amount of energy provided by their respective combustion gases, in order to ensure that the needleless injector is able to deliver the injection objective substance to the target region at the desired depth (Suzuki [0061], [0085]). It would have been obvious to modify the ignition agent and the gas generating agent of Suzuki such that the ignition agent generates a combustion gas with an energy value from 1.0 mol∙K to 2.5 mol∙K, and the gas generating agent generates a combustion gas with an energy value from 6.1 mol∙K to 8.5 mol∙K because it has been held that discovering the optimum value of a result effective variable involves only routine skill in the art through routine experimentation (MPEP 2144.05(II)).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEAH J SWANSON whose telephone number is (571)270-0394. The examiner can normally be reached M-F 9 AM- 5 PM ET.
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/LEAH J SWANSON/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
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