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 .
Claim Rejections - 35 USC § 103
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.
Claim(s) 1, 9-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Joseph et al. (BR PI0415629) in view of Juan (CN 111649927) and Hendon et al. (US 2021/0239450).
Regarding to claims 1 and 12:
Joseph et al. discloses a test device for microneedle systems, comprising:
a microneedle receptacle for receiving a microneedle system to be tested (FIG. 1: The microneedle 64 and the microneedle receptacle 60);
an application system including a skin model or configured to receive a skin model (FIG. 1, element 5); and
a movement device comprising a punch for the application movement of the microneedle system to be tested into the application device (FIG. 1: The punch (30, 32) moves along the direction A); and
a variably adjustable spacer for defining a vertical distance between the punch and the application device or the skin model (FIGs. 1-6 show the variation of the distance between the punch (30, 32) and the skin model 5).
Joseph et al. however does not teach a sensor device for detecting an application of the microsystem into the application device, the sensor device comprising a sensor, wherein the sensor is an OCT sensor.
Yuan discloses a microneedle system comprising a sensor device for detecting an application of the microsystem into the application device, the sensor device comprising a sensor (FIGs. 3 and 7: The sensor 24 and the camera 42).
Therefore, it would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify the sensor in Joshep’s system to include a sensor device as disclosed by Yuan for obtaining a detection image in order to be able to evaluate the mechanical property of the microneedle system (Abstract).
In addition, Hendon et al. discloses a system for generating an image of a sample comprising an image arrangement that can be an optical coherence tomograph imaging (OCT) arrangement (Abstract).
Therefore, it would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify the sensor in Joshep’s system, as modified in view of Yuan, to be an OCT sensor to be able to capture of three-dimensional images at micron resolution over a larger field of view than what is possible using traditional technique as taught by Hendon et al. (paragraph [0005]).
Yuan further discloses the following claims:
Regarding to claim 9: wherein the sensor device is configured to detect a penetration depth of the microneedle system into the application device or to detect a force between the microneedle system and the application system (FIG. 9 shows the image of the depth that the microneedle 5 penetrates into the skin simulacrum 6).
Regarding to claim 10: wherein the sensor device comprises a piezoelectric sensor which is in particular connected to the application device; or a preferably magnetic force transducer which is in particular connected to the application device or the punch (FIG. 3: The sensor 24 is a mechanical sensor. It is a conventional structure of a mechanical sensor comprising a piezoelectric element. Please see Brederlow et al. (WO 02/075296), FIG. 3a, paragraph [0091]).
Regarding to claim 11: further comprising a fixable guide device for guiding the movement device relative to the application device (FIG. 3: The sliding frame/housing 26-27).
Regarding to claim 13: A method for testing a microneedle application with a test device, comprising the steps of accelerating a microneedle system comprising microneedle, applying the microneedle system into an application device which preferably includes a skin model, and detecting the application of the microneedle system by determining at least one of a penetration depth or an application force, by means of a sensor device comprising at least one sensor (FIGs. 3 and 7: The motor 21 drives the sliding table 231 to punch (accelerate) the microneedle 5 to the application system 32 having the skin model 6. The camera 42 captures the image of the depth that the microneedle 5 penetrates into the skin simulacrum 6 as shown in FIG. 9).
Regarding to claim 14: A method for testing a microneedle application with a test system, comprising the steps of: accelerating a microneedle system comprising microneedles; applying the microneedle system into an application device which preferably includes the skin model; and detecting the application of the microneedle system by determining at least one of a penetration depth or an application force by means of a sensor device preferably comprising at least one sensor (FIGs. 3 and 7: The motor 21 drives the sliding table 231 to punch (accelerate) the microneedle 5 to the application system 32 having the skin model 6. The camera 42 captures the image of the depth that the microneedle 5 penetrates into the skin simulacrum 6 as shown in FIG. 9).
Regarding to claims 15-16: wherein the vertical distance between the punch and the application device or the skin model provided by the variably adjustable spacer is altered using an adjusting nut, wherein the variably adjustable spacer provides an adjustable vertical distance of between 1 mm and 5 mm (Joseph et al: FIGs. 1-3 show the adjusting nut 20 varies the spacing along the arrow A. In addition, it would have been obvious to one having ordinary skill in the art at the time the invention was made to set such spacing in the range as claimed, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F. 2d 272, 205 USPQ 215 (CCPA 1980)).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAM S NGUYEN whose telephone number is (571)272-2151.
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/LAM S NGUYEN/ Primary Examiner, Art Unit 2853
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