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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/13/2026 has been entered.
Status of the Claims
Claims 2-3 are cancelled. Claims 1 and 4-6 are currently pending. Claims 1 and 4-6 are currently rejected.
Response to Arguments
Applicant's arguments filed 04/13/2026 have been fully considered but they are not persuasive.
Examiner notes that the amendments to claims 1 and 5 overcome the previous 112b rejections, which are thus not extended to the claims as currently amended.
Examiner acknowledges that the subject matter of cancelled claims 2-3 has been incorporated into independent claim 1 as currently amended. However, although page 5 of the remarks asserts that an additional limitation has been added to claim 1, the currently filed claim set does not reflect this amendment, and thus this proposed amendment is not considered to be part of claim 1.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., "a wall thickness of a part of the second housing configured to surround the combustion chamber is smaller than a wall thickness of a part of the second housing configured to surround the predetermined path.", noted on Remarks page 5) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Claim Objections
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 4 is objected to because line 1 reads “The needleless injector according to claim 3”, but claim 3 has been cancelled. Claim 4 line 1 should read “The needless injector according to claim 1[[3]]” For the purposes of examination, claim 4 is interpreted to depend from claim 1. 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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1 and 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over Arnitz et al (EP 1570875 A1; hereafter Arnitz) in view of Yamada et al (EP 3480839 A1; hereafter Yamada) and further in view of Aschenbrenner (DE 10215297 A1; hereafter Aschenbrenner), Haitsuka (US 20160129190 A1; hereafter Haitsuka), and Haar (US 6258063 B1; hereafter Haar). Text references are made to the previously included copies of Arnitz, Yamada, and Aschenbrenner.
Regarding claim 1, Arnitz discloses a needleless injector ([0083] Figures 1 through 3 show a first embodiment of a jet injector/injection unit 1) comprising:
an injector body (polymer shell 18 and rear housing 20, fig. 1, [0088] The glass medication cylinder 7 is enclosed in a polymer shell 18 that screws with a thread 19 to the rear housing 20.) comprising a first housing (rear housing 20) and a second housing (polymer shell 18);
an igniter (igniter tube 3, fig. 1, [0083]) that is provided in the injector body (see fig. 1, igniter tube 3 lies partially in the injector body 20/18), and configured to discharge, into a combustion chamber (propellant chamber 4, fig. 1, [0087]) in the injector body (see fig. 1), ejection energy for ejecting an injection substance ([0091] Figure 3 shows the injection unit after ignition of the primer material 13 and ejection of the medication through the nozzle 8 when the power piston 10 and the medication piston 9 have reached their end points) through combustion of an ignition charge (propellant 14, fig. 1, [0087]) ([0087] striking the metal tube provides sparks to the propellant chamber 4 causing ignition of the propellant 14);
a housing part (glass medication cylinder 7, fig. 1, [0083]) including an accommodating space (see fig. 2 which shows the accommodating space within the cylinder 7 proximal to the piston 9) in which the injection substance is accommodated (note [0083] glass medication cylinder 7 contains the liquid medication), the housing part (7) defining a flow path (see fig. 1, the flow path is the narrowing interior of the cylinder 7 and the channel from the interior of cylinder 7 to the ejection port/jet nozzle 8) configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to allow the injection substance to be ejected to a target region through an ejection port (jet nozzle 8, fig. 1, [0083] liquid medication is ejected through jet nozzle 8), and the housing part (7) being provided to the injector body (20) ([0088] polymer shell 18 encloses cylinder 7 and screws with a thread 19 to the rear housing 20, see fig. 1); and
a piston (power piston 10, fig. 1, [0084]) that is configured to (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) be moved by the ejection energy in a predetermined path (power cylinder 5, fig. 1) ([0084] power piston 10 in the power cylinder 5 is actuated by a mechanically ignited pyrotechnic gas generator 11), communicating with the combustion chamber (propellant chamber 4) (see fig. 1, note that propellant chamber 4 is part of gas generator 11), in the injector body (20) to pressurize the injection substance accommodated in the accommodating space (interior of cylinder 7) [0084] movement of piston 10 causes expulsion of liquid medication through jet nozzle 8), wherein
the injector body (20/18) is provided with a reinforcing member (steel shell 2, fig. 1 and figs. 4 and 5, [0083]) therein, the reinforcing member (2) being made of a metal ([0083] shell 2 is a steel shell) and configured to be tubular ([0085] metal shell 2 has a diameter forming a wall), the reinforcing member (2) configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to extend in an axial direction of the injector body (20/18) (see figs. 1, 4, and 5 for axial extension which injector body 20) while being configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to surround at least the igniter (3) ([0083] steel shell 2 includes an igniter tube 3) and the combustion chamber (4) ([0083] steel shell 2 includes a propellant chamber 4),
wherein the needleless injector is configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to eject an injection substance (see 112b interpretation above) to a target region without using an injection needle ([0084] medication is expelled through jet nozzle 8, see fig. 1), and
wherein the reinforcing member (2, fig. 1) is configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to extend in the axial direction of the injector body (20, fig. 1), and is configured to surround at least a part of the predetermined path (power cylinder 5, fig. 1, [0083] steel shell 2/reinforcing member 2 includes power cylinder bore 5), in addition to being configured to surround the igniter (3, fig. 1) and the combustion chamber (4, fig. 1) (fig. 1 shows that the reinforcing member 2 extends in the axial direction and additionally surrounds at least part of the power cylinder 5 in which the piston 10 slides as noted in [0084]).
Arnitz is silent to the injector body being made of a resin, the reinforcing member embedded in the injector body, and the reinforcing member being disposed to be sandwiched between the first housing and the second housing of the injector body in a radial direction of the injector body.
Yamada, in the art of housing for igniters used to drive movement, teaches an injector body (housing 10, fig. 1, [0042]) made of a resin ([0042] housing (resin housing) 10 made of a synthetic resin), a reinforcing member (reinforcing frame 70, fig. 1, [0065]) embedded in the injector body ([0068] The reinforcing frame 70 may be embedded in the resin housing 10 as a whole), the reinforcing member (70) being disposed to be sandwiched between the first housing (portion of injector body 10 radially inside of the reinforcing member/frame 70; see Yamada Modified Fig-1 below) and the second housing (portion of injector body 10 radially outside of the reinforcing member/frame 70; see Yamada Modified Fig-1 below) of the injector body (10) in a radial direction of the injector body (see Yamada Modified Fig-1 below).
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It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the injector body of Arnitz with the resin housing of Yamada since both structures are meant to withstand and direct force from an ignition reaction. One would have been motivated to modify the injector body to be resin since both references deal with electronic components of igniters and, as noted by Yamada [0062], resin has an electric insulation property, so the resin would serve to prevent electronic components from interacting improperly through the housing/injector body. One would have been further motivated to include the reinforcing frame because, as noted by Yamada [0075], when including the metal reinforcing frame 70, the thickness of the housing 10 can be reduced and the entire device can be downsized. This modification would thus facilitate better stability and portability of the device. Note that the first housing (rear housing 20) and second housing (polymer shell 18) of Arnitz overlap as shown in fig. 1. The reinforcement member (2) of Arnitz would be embedded throughout the length of the rear housing 20 and overlapping within the polymer shell/second housing 18 such that the interface of the first and second housings would also be beneficially reinforced.
Alternatively, Arnitz modified by Yamada is silent to the reinforcing member being disposed to be sandwiched between the first housing and the second housing of the injector body in a radial direction of the injector body.
Aschenbrenner, in the art of injection devices with gas generators, teaches a reinforcing member (sliding sleeve 47, fig. 1, [0036]) being disposed to be sandwiched between the first housing (housing part 4a, fig. 1, [0033]) and the second housing (housing part 4b, fig. 1, [0033]) of the injector body (housing 4, fig. 1, [0033]) in a radial direction of the injector body (see fig. 1 which shows reinforcing member/sliding sleeve 47 radially disposed between housing parts 4a and 4b).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the device of Arnitz modified by Yamada with the teachings of Aschenbrenner since Aschenbrenner also deals with propulsion initiated by igniting propellant. One would have been motivated to make the modification because having the reinforcing member disposed to be sandwiched between the first housing and the second housing of the injector body provides support along what may otherwise be a weak point where the housing portions are thinner where they connect with one another.
Arnitz as modified it silent to the thickness of the injector body varying as claimed.
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Haitsuka, in the art of medical injectors using igniters ([0043] initiator 20 is an electric igniter), teaches wherein: a wall thickness of a part of the injector body (housing 2, fig. 5, [0042]) forming the combustion chamber (combustion chamber 6, fig. 5, [0044]) is smaller than a wall thickness of a part of the injector body (2, fig. 5) forming the predetermined path (through-hole 7, fig. 5, [0047]) (see annotated fig. 5 above, the wall thickness of the injector body 2 is thinner surrounding the combustion chamber 6, as noted by the solid double-sided arrow, and is thicker surrounding the predetermined path 7 as shown by the dotted double-sided arrow).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to further modify the injector body of Arnitz as modified to include the thinner portion surrounding the combustion chamber and the thicker portion surrounding the predetermined path since both references deal with needleless drug injection powered by ignition and the injector body of Arnitz as modified is similar to Haitsuka in that both are formed of resin (Haitsuka: [0042] the housing 2 is manufactured by injection molding of resin). One would have been motivated to make the modification because having a smaller piston face pushed on by the same pressure would allow a higher concentration of force per area and facilitate faster movement of the piston and thus faster injection speeds, better ensuring clean penetration of the fluid into the patient.
Arnitz as modified is silent to the thickness of the reinforcing member varying as claimed.
Haar, in the art of hypodermic injection systems using pressure to penetrate the skin (Abstract), teaches wherein a wall thickness of a first portion (overlapping portion of inner shell 54 and outer shell 55, see annotated fig. 10 portion A-B, see col. 17 ln. 1-26) of the reinforcing member (inner shell 54 and outer shell 55, fig. 10, col. 17 ln. 1-26) configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to surround the igniter (explosive 93, fig. 10, col. 17 ln. 1-26) and the combustion chamber (explosion chamber 92, fig. 10, col. 17 ln. 1-26) is larger than a wall thickness of a second portion (portion of outer shell 55 which is not overlapped by inner shell 54, see annotated fig. 10 portion B-C) of the reinforcing member (54/55) configured to surround a predetermined path (see fig. 10, distal end of reinforcing member portion/outer shell 55 which surrounds the medication unit 51 is not overlapped by the inner shell 54 making the side of the reinforcing member 54/55 farthest from the combustion chamber less thick than the rest of the reinforcing member).
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It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the device of Arnitz as modified to have a thicker reinforcing member composed of two layers surrounding the igniter and combustion chamber and a thinner portion along the rest of the length as taught by Haar since Haar also deals with combustion powered fluid injection. One would have been motivated to make the modification because the additional layer of reinforcing member around the igniter and combustion chamber would help to withstand the pressure generated by the combustion, since as noted in Haar col. 14 ln. 28-31, the inner shell 54 which is made from a material that can withstand pressures generated within the explosion chamber.
Regarding claim 4, Arnitz as modified and applied to claim 1 above discloses the needleless injector according to claim 3 (see 112(d) objection above, claim 4 interpreted to depend from claim 1), including wherein the reinforcing member (steel shell 2 shown in fig. 1 of Arnitz) comprising a plurality of stacked tubular sub members (inner shell 54 and outer shell 55 as taught by Haar fig. 10 and used to modify the steel shell 2 of Arnitz as described in the 103 rejection of claim 3 above) made of metal (see Arnitz [0083] shell 2 is a steel shell; note Haar col. 14 ln. 31-39 which says that the inner shell 54 and outer shell 55 may be formed of metal such as steel) and having different diameters (see nested shells 54/55 in fig. 10 of Arnitz), and a number of the plurality of stacked sub members corresponding to the first portion (section A-B of reinforcing member 54/55 includes both inner shell 54 and outer shell 55, as shown in annotated fig. 10 of Haar above) is larger than a number of the stacked sub members corresponding to the second portion (B-C of reinforcing member 54/55 includes only outer shell 55, as shown in annotated fig. 10 of Haar above).
Regarding claim 5, Arnitz as modified and applied to claim 1 discloses the needleless injector according to claim 1, as described above, including wherein the injector body (Arnitz: 20/18, fig. 1) includes the first housing (Arnitz: 20, fig. 1) provided with the igniter (Arnitz: 3, fig. 1) and the second housing (Arnitz: 18, fig. 1) provided with the housing part (Arnitz: 7, fig. 1), and
the reinforcing member (Arnitz: 2, fig. 1) is either disposed on a surface of the first housing (Arnitz: 20) (Arnitz: see fig. 1 and figs. 4 and 5 which shows that the reinforcing member 2 is disposed on a surface of the first housing 20) or (Examiner notes that this limitation is in the alternative, and the prior art need only satisfy one alternative.) disposed on a surface of the second housing, such that when the first housing (see Yamada Modified Fig-1 above, and/or Aschenbrenner housing portion 4a in fig. 1) and the second housing (see Yamada Modified Fig-1 above, and/or Aschenbrenner housing portion 4b in fig. 1) are attached to each other to achieve a state where the reinforcing member (Yamada: 70, fig. 1 and/or Aschenbrenner: 47, fig. 1) is sandwiched between the first housing and the second housing (see Yamada Modified Fig-1 and fig. 1 of Aschenbrenner).
Regarding claim 6, Arnitz as modified and applied to claim 1 discloses the needleless injector according to claim 1, as described above.
Arnitz is silent to an additional reinforcing member.
Yamada further discloses an additional reinforcing member (cylinder 30, fig. 1, [0047] The cylinder 30 shown in Figure 1 is provided to reinforce the housing 10) made of a metal ([0047] cylinder 30…is elected from those made of metal such as stainless steel and aluminum) and configured to be tubular (note cylinder 30 is a cylinder), and configured to form a surface on which the piston (projectile 40, fig. 1, [0003] A known electric circuit breaker device contains, in a housing, an igniter, a projectile (piston); see [0074] and [0080]) slides ([0074] The projectile 40 is attached by being press-fitted into the cylinder 30; [0080] Upon receipt of the pressure of the combustion products, the projectile 40 moves in the axial direction), on a surface of a part of the injector body (see fig. 1 which shows injector body/housing 10 surrounding piston/projectile 40) forming the predetermined path (axial direction noted in [0080]).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to further modify the device of Arnitz modified by Yamada and Aschenbrenner as applied to claim 1 to have the additional reinforcing member/cylinder 30 of Yamada since, as previously noted, all references include structures meant to withstand and direct force from an ignition reaction. One would have been, as previously noted, motivated to include the additional reinforcing member because, as noted by Yamada [0075], when including the metal cylinder 30, the thickness of the housing 10 can be reduced and the entire device can be downsized. This modification would thus further facilitate better stability and portability of the device.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Haar (US 20030114789 A1) - fig. 10a and fig. 12 shows a housing layer 20 which is thicker around a predetermined path than around a propellant container 23; fig. 20 shows a housing layer 20 with similar conditions
Alexandre (US 6942645 B2) - figs. 1 and 2 show a housing layer have a thicker portion around a piston path and reservoir 2 than around the threaded connection with the body 71 comprising pyrotechnic charge 72
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/I.S.N./Examiner, Art Unit 3783
/JASON E FLICK/Primary Examiner, Art Unit 3783 08/22/2026
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