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 on 05/01/2026 has been entered. Claims 1-2, 11-13, and 15 have been amended. Claims 3-10, and 14 are in the original/previously presented form. Thus, claims 1-15 remain pending in the application.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Drawings
The amendment to the drawings were received on 05/01/2026. Applicant addressed all previous objections. The drawings are acceptable.
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.
Claims 1, 2, 14, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Raidt et al. (United States Patent No. US 10,285,791 B2; herein, Raidt), and further in view of Fachinger et al. (United States Patent Application Publication No. US 2020/0023128 A1; herein, Fachinger).
Regarding claim 1, Raidt discloses a device for the injection of a fluid into an animal (injection device 10),comprising:
a contact device (contact device 14), comprising a shaped contact surface (shaped contact area 34) that is shaped in conformity with a body part of the animal to which the injection is to be administered (col. 11 lines 1-4);
a first injector (syringes 28), comprising a front dispensing end (needle 30) which, extends through a first passage opening in the shaped contact surface and protrudes in relation to the shaped contact surface in a region adjacent to the first passage opening (col. 11 lines 20-26); and
a control unit (control device S) that activates injection via the first injector on the basis of the at least one first measuring signal (col. 12 line 66-col. 13 line 2).
Raidt does not disclose that the injection device is needle-free and a first measuring device that detects a force exerted on the first injector by the animal pressing against the front dispensing end of the first injector and outputs at least one first measuring signal corresponding to contact of the animal with the front dispensing end of the first injector.
However, Fachinger teaches a needle-free injection device (FIG. 1, [0022]) and a first measuring device (FIG. 3, pressure sensor 12) that detects a force exerted on the first injector by the animal pressing against the front dispensing end of the first injector ([0033], “pressure sensor is positioned in the front of injector and is movable with respect to the housing by applying pressure, e.g. when the injector is pressed against the skin of the animal to be injected”) and outputs at least one first measuring signal corresponding to contact of the animal with the front dispensing end of the first injector ([0018], [0037], “pressure sensor is connected to a first switching means” and switch is activated when front of injector is moved towards the housing). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the syringe and needle injection instrument disclosed by Raidt with the needleless injector taught by Fachinger in order to eliminate needlestick injuries for the administrator and the animal being injected, as well as allowing for easier mass vaccinations ([0003]). Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed by Raidt to include a first measuring device which detects a force on an injector by an animal pressing against it as taught by Fachinger in order that the device be actuated by a selected amount of axial pressure applied directly to the source of injection ([0033]).
Regarding claim 2, in the modified device of Raidt, Raidt does not disclose a first linear guide that carries the first injector, first linear guide mounted movably along a first displacement direction between a front end position and a triggering position and stops under spring pretensioning in the front end position, wherein the first measuring device outputs the at least one first measuring signal when the triggering position is reached by the first injector. However, Fachinger teaches a first linear guide that carries the first injector ([0018], drive means), first linear guide mounted movably along a first displacement direction between a front end position and a triggering position ([0022], “piston is movable in a second direction opposite to the first direction by actuation of the drive means”) and stops under spring pretensioning in the front end position ([0022], “a preferred position at which the volume of said chamber is at a minimum and the spring is nearly unloaded”), wherein the first measuring device outputs the at least one first measuring signal when the triggering position is reached by the first injector ([0028], “the supply-line is provided with a sensor for detecting the presence of liquid for injecting purposes, whilst the operation of the drive means is dependent on the sensor”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified device disclosed by Raidt to specify a means for moving the injector similar to that of the drive means as taught in Fachinger in order to provide clarity to the operation of the injection ([0018]). Furthermore in regards to the operation of the injection, it would have been obvious to modify the modified injection device of the Raidt with the spring component taught by Fachinger, allowing for the injections to be more consistent and precise in the amount of fluid being pushed ([0022]), as springs are a known component used in the autoinjector industry.
Regarding claim 14, in the modified device of Raidt, Raidt discloses wherein the first injector is a self-filling syringe (col. 10 line 50-52).
Regarding claim 15, in the modified device of Raidt, Raidt discloses a second injector (col. 10 line 50-52, injection instrument 26 comprises two syringes 28), which comprises a front dispensing end (needle 30) which, extends through a second passage opening in the shaped contact surface and protrudes in relation to the shaped contact surface in a region adjacent to the second passage opening (col.11 lines 20-26), wherein the control unit activates injection via the second injector on the basis of the at least one second measuring signal (col. 12 line 66 – col. 13 line 3).
Raidt does not disclose that the injection device is needle-free and a second measuring device which detects a force exerted on the second injector by the animal pressing against the front dispensing end of the second injector and outputs at least one second measuring signal corresponding to contact of the animal with the front dispensing end of the second injector. However, Fachinger teaches a needle-free injection device (FIG. 1, [0022]) and a second measuring device (FIG. 3, there are two pressure sensors 12) which detects a force exerted on the second injector by the animal pressing against the front dispensing end of the second injector ([0033], “pressure sensor is positioned in the front of injector and is movable with respect to the housing by applying pressure, e.g. when the injector is pressed against the skin of the animal to be injected”) and outputs at least one second measuring signal corresponding to contact of the animal with the front dispensing end of the second injector ([0018], [0037], “pressure sensor is connected to a first switching means” and switch is activated when front of injector is moved towards the housing). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the syringe and needle injection instrument of the modified device disclosed by Raidt with the needleless injector taught by Fachinger in order to eliminate needlestick injuries for the administrator and the animal being injected, as well as allowing for easier mass vaccinations ([0003]). Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified device disclosed by Raidt to include a first measuring device which detects a force on an injector by an animal pressing against it as taught by Fachinger in order that the device be actuated by a selected amount of axial pressure applied directly to the source of injection ([0033]).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Raidt in view of Fachinger as applied to claim 2 above, and further in view of Hunter et al. (United States Patent No. US 8,328,755 B2; herein, Hunter).
Regarding claim 3, in the modified device of Raidt, Raidt does not disclose the first measuring device contactlessly detects the reaching of the triggering position. However, Hunter teaches a first measuring device contactlessly detects the reaching of the triggering position (FIGURE 2A, col. 10 lines 19-32, magnet assembly 205 including magnets 204A, 204B and coil assembly 203 generate mechanical force for the electromagnetic actuator 200). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first measuring device taught by Fachinger and control unit and actuator in the modified device disclosed by Raidt with the electromagnetic actuator, magnet and coil assemblies taught by Hunter in order for increased controllability of the actuator leads to more precise transfer of substance (col. 10 lines 42-43), as well as less mechanical wear as contact dependent counterparts.
Claims 4-9 are rejected under 35 U.S.C. 103 as being unpatentable over Raidt in view of Fachinger as applied to claims 1 and 2 above, and further in view of Lerner et al. (United States Patent Application Publication No. US 2012/0078224 A1; herein, Lerner).
Regarding claim 4, in the modified device of Raidt, Raidt does not disclose the contact surface is mounted displaceably between a main position and an injection position, wherein, in the main position of the contact surface, the front dispensing end of the first injector does not extend through the first passage opening in the shaped contact surface, and, in the injection position of the contact surface, the front dispensing end of the first injector extends through the first passage opening in the shaped contact surface and protrudes in relation to the shaped contact surface in a region adjacent to the first passage opening.
However, Lerner teaches the contact surface (ocular contact surface 108) is mounted displaceably between (FIG. 29 and FIG. 30) a main position ([0133], non-deployed state) and an injection position ([0141], deployed state), wherein, in the main position of the contact surface, the front dispensing end of the first injector (dispensing member (conduit) 11) does not extend through the first passage opening in the shaped contact surface ([0133], non-deployed (pre deployed) state, the conduits will generally reside within the housing), and, in the injection position of the contact surface, the front dispensing end of the first injector (dispensing member 11) extends through the first passage opening in the shaped contact surface and protrudes in relation to the shaped contact surface in a region adjacent to the first passage opening ([0133], deployed state…the conduit, or a portion thereof, will typically extend from the housing). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the pillar support elements and cylindrical cavities of the contact device disclosed by the modified Raidt to displaceably mount the contact surface between a main position and an injection position, wherein, in the main position of the contact surface, the front dispensing end of the first injector does not extend through the first passage opening in the shaped contact surface, and, in the injection position of the contact surface, the front dispensing end of the first injector extends through the first passage opening in the shaped contact surface and protrudes in relation to the shaped contact surface in a region adjacent to the first passage opening as taught by Lerner in order to prevent contact with the injector prior to use ([0141]). This would result in the pillar-shaped support elements 40a-40c having a translatable conduit structure as shown in Lerner’s FIG. 29-30 enabling the function of displaceable mounting.
Regarding claim 5, in the modified device of Raidt, Raidt discloses the contact surface is mounted in such a manner that the contact surface is in the main position without an animal pressed against it (col. 3 lines 15-23), and that the contact surface is movable into the injection position only upon a predetermined force being exceeded by the animal pressing against it (col. 3 lines 15-23). The examiner considers the movement of the contact device from a pre-contact position to a post-contact position as described in the prior art of Raidt as equivalent to the movement of a contact surface from a main position to an injection position.
Regarding claim 6, in the modified device of Raidt, Raidt discloses the contact surface (contact device 14). Raidt does not disclose the contact surface being held in the main position under spring pretensioning. However, Fachinger teaches the contact surface being held in the main position under spring pretensioning ([0022], “a preferred position at which the volume of said chamber is at a minimum and the spring is nearly unloaded”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the contact device disclosed by modified Raidt with the spring taught by Fachinger, as springs are a known operation element is the autoinjector industry due to their ability to return to original setting without much displacement.
Regarding claim 7, in the modified device of Raidt, Raidt does not disclose the contact surface is mounted displaceably between a main position and an injection position, wherein, in the main position of the contact surface, the front dispensing end of the first injector does not extend through the first passage opening in the shaped contact surface, and, in the injection position of the contact surface, the front dispensing end of the first injector extends through the first passage opening in the shaped contact surface and protrudes in relation to the shaped contact surface in a region adjacent to the first passage opening.
However, Lerner teaches the contact surface (ocular contact surface 108) is mounted displaceably between (FIG. 29 and FIG. 30) a main position ([0133], non-deployed state) and an injection position ([0141], deployed state), wherein, in the main position of the contact surface, the front dispensing end of the first injector (dispensing member (conduit) 11) does not extend through the first passage opening in the shaped contact surface ([0133], non-deployed (pre deployed) state, the conduits will generally reside within the housing), and, in the injection position of the contact surface, the front dispensing end of the first injector (dispensing member 11) extends through the first passage opening in the shaped contact surface and protrudes in relation to the shaped contact surface in a region adjacent to the first passage opening ([0133], deployed state…the conduit, or a portion thereof, will typically extend from the housing). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the pillar support elements and cylindrical cavities of the contact device disclosed by the modified Raidt to displaceably mount the contact surface between a main position and an injection position, wherein, in the main position of the contact surface, the front dispensing end of the first injector does not extend through the first passage opening in the shaped contact surface, and, in the injection position of the contact surface, the front dispensing end of the first injector extends through the first passage opening in the shaped contact surface and protrudes in relation to the shaped contact surface in a region adjacent to the first passage opening as taught by Lerner in order to prevent contact with the injector prior to use ([0141]). This would result in the pillar-shaped support elements 40a-40c having a translatable conduit structure as shown in Lerner’s FIG. 29-30 enabling the function of displaceable mounting.
Regarding claim 8, in the modified device of Raidt, Raidt discloses the contact surface is mounted in such a manner that the contact surface is in the main position without an animal pressed against it (col. 3 lines 15-23), and that the contact surface is movable into the injection position only upon a predetermined force being exceeded by the animal pressing against it (col. 3 lines 15-23). The examiner considers the movement of the contact device from a pre-contact position to a post-contact position as described in the prior art of Raidt as equivalent to the movement of a contact surface from a main position to an injection position.
Regarding claim 9, in the modified device of Raidt, Raidt discloses the contact surface (contact device 14). Raidt does not disclose the contact surface being held in the main position under spring pretensioning. However, Fachinger teaches the contact surface being held in the main position under spring pretensioning ([0022], “a preferred position at which the volume of said chamber is at a minimum and the spring is nearly unloaded”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the contact device disclosed by modified Raidt with the spring taught by Fachinger, as springs are a known operation element is the autoinjector industry due to their ability to return to original setting without much displacement.
Claims 10 is rejected under 35 U.S.C. 103 as being unpatentable over Raidt further in view of Fachinger as applied to claim 1 above, and further in view of Smith et al. (United States Patent Application No. US 2007/0093747 A1; herein, Smith).
Regarding claim 10, in the modified device of Raidt, Raidt does not disclose the fluid volume dispensed during the needle-free injection is adjustable. However, Smith teaches the fluid volume dispensed during the injection is adjustable ([0026], the dosage from each dosage device 24 can be a different quantity). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to specify the volume held within the syringes of the modified device disclosed by Raidt with the adjustable characteristic taught by Smith in order to allow for flexible dosing patterns between animals ([0026]).
Further, Fachinger teaches the injection being needle-free (FIG. 1, [0022]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the syringe and needle injection instrument of the modified device disclosed by Raidt with the needleless injector taught by Fachinger in order to eliminate needlestick injuries for the administrator and the animal being injected, as well as allowing for easier mass vaccinations ([0003]).
Claims 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Raidt in view of Fachinger as applied to claim 1 above, and further in view of Moons (United States Patent No. US 10,588,729 B2).
Regarding claim 11, in the modified device of Raidt, Raidt does not disclose the control unit activates the needle-free injection when a predetermined limit value of the at least one first measuring signal is exceeded. However, Moons teaches the control unit activates the injection when a predetermined limit value of the at least one first measuring signal is exceeded (Fig. 4, col. 3 lines 53-61, if forces are within threshold value, injection is triggered by control unit). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified device disclosed by Raidt with the control algorithm taught by Moons in order for the control unit to autonomously function when the force sensors detect a change, as well as ensure that no animal will be vaccinated twice (col. 3 line 53 – col. 4 line 3).
Further, Fachinger teaches the injection being needle-free (FIG. 1, [0022]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the syringe and needle injection instrument of the modified device disclosed by Raidt with the needleless injector taught by Fachinger in order to eliminate needlestick injuries for the administrator and the animal being injected, as well as allowing for easier mass vaccinations ([0003]).
Regarding claim 12, in the modified device of Raidt, Raidt discloses the first measuring device further detects a force exerted on the contact surface by the animal pressing against the contact surface (col. 12 line 57 – col. 13 line 3). Raidt does not disclose the first measuring device outputs second measuring signals to the control unit which triggers the needle-free injection when a predetermined limit value is exceeded. However, Moons teaches the first measuring device outputs second measuring signals to the control unit which triggers the injection when a predetermined limit value is exceeded (Fig. 4, col. 3 lines 53-61, if forces are within threshold value, injection is triggered by control unit). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified device disclosed by Raidt with the control algorithm taught by Moons in order for the control unit to autonomously function when the force sensors detect a change, as well as ensure that no animal will be vaccinated twice (col. 3 line 53 – col. 4 line 3).
Further, Fachinger teaches the injection being needle-free (FIG. 1, [0022]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the syringe and needle injection instrument of the modified device disclosed by Raidt with the needleless injector taught by Fachinger in order to eliminate needlestick injuries for the administrator and the animal being injected, as well as allowing for easier mass vaccinations ([0003]).
Regarding claim 13, in the modified device of Raidt, Raidt discloses the first measuring device further comprises a proximity sensor (capacitive sensor 46) which detects the presence of the animal at the contact surface (col. 12 lines 24-25). Raidt does not disclose the first measuring device outputs a second measuring signal to the control unit corresponding to the proximity sensor which triggers the needle-free injection on the basis of the second measuring signal. However, Moons teaches the first measuring device outputs a second measuring signal to the control unit corresponding to the proximity sensor which triggers the injection on the basis of the second measuring signal (Fig. 4, col. 3 lines 53-61, if forces are within threshold value, injection is triggered by control unit). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the capacitive sensor and output of Raidt with the control algorithm of Moons in order for the control unit to autonomously function when the force sensors detect a change, as well as ensure that no animal will be vaccinated twice (col. 3 line 53 – col. 4 line 3).
Further, Fachinger teaches the injection being needle-free (FIG. 1, [0022]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the syringe and needle injection instrument of the modified device disclosed by Raidt with the needleless injector taught by Fachinger in order to eliminate needlestick injuries for the administrator and the animal being injected, as well as allowing for easier mass vaccinations ([0003]).
Response to Arguments
Applicant’s arguments, see page 7 of Applicant’s Remarks filed 05/01/2026, with respect to claim 1 have been considered but are moot because the arguments do not apply in view of the new grounds of rejection. The amended limitation “detects a force exerted on the first injector by the animal pressing against the front dispensing end of the first injector” is interpreted by the examiner as being anticipated by Fachinger, as parts of claim 1 were in the previous office action, filed 01/02/2026.
Conclusion
Applicant's amendment necessitated the new ground 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 Evelyn A Thoman whose telephone number is (571)272-8496. The examiner can normally be reached Monday-Friday 8:00 a.m-4:30 p.m..
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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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/EVELYN A THOMAN/Patent Examiner, Art Unit 3783
/MICHAEL J TSAI/ Supervisory Patent Examiner, Art Unit 3783
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