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
This office action is responsive to the amendment filed on 08/29/2025. As directed by the amendment: claims 1 – 9, 11, 14, and 15 have been amended, and claim 16 has been added. Thus, claims 1 – 16 are presently pending in this application with claims 14 and 15 currently withdrawn from consideration.
Response to Arguments
Applicant’s arguments, see pages 6 – 11, filed 08/29/2025, with respect to the rejection(s) of claim(s) 1 - 13 under 35 U.S.C. 102 and 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Trautman (U.S. 2005/0096586).
Specifically, Trautman teaches every limitation of the newly amended claim including a device for applying a microneedle array (applicator 10, Figures 1 – 3) having an actuating device (outer cup 20, Figure 1) which holds the plunger (piston 30, Figure 1) in a first position (in the position as shown in Figure 1) and, by actuating the actuating device, releases the plunger for displacement purposes such that the plunger is moved in the direction of the microarray device so as to contact the microarray device thereby causing the microarray device to move (outer cup 20 is pressed to release catches 38 and allow spring 40 to move the piston 30 downward and impact the target site with patch 60 as discussed in paragraph [0093]), wherein the actuating device comprises at least two separate actuators (two flexible catches 38 as shown in Figure 1), and wherein release of the plunger by the actuating device takes place only upon a preferably cumulative actuation of the at least two actuators (actuating both flexible latches 38 as discussed in paragraph [0093]), and wherein the cumulative actuation comprises a simultaneous actuation in which the at least two actuators are actuated at essentially the same moment (both flexible catches 38 are actuated by spring guide 22 at essentially the same moment when outer cup 20 is pressed down as discussed in paragraph [0093] and shown in Figures 1 – 3).
See rejections below for more details.
Claim Objections
All previous objections have been overcome by Applicant’s amendments.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “a microarray” in line 1, “a microarray device” in lines 4 and 7, and “the microarray device” in lines 10 and 11. It is unclear whether these limitations are referring to the same microarray device. Applicant is advised to amend the claim as follow in order to overcome this rejection:
“a microarray” in line 1 should read “a microarray device”
“a microarray device” in lines 4 and 7 should read “the microarray device”
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1 – 10, and 16 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Trautman (U.S. 2005/0096586).
Regarding claim 1, Trautman teaches an applicator (applicator 10, Figure 1) for applying a microarray device (microprojection array 64, Figure 1), comprising
a housing (housing 12, Figure 1),
a plunger (piston 30, Figure 1) linearly movably arranged in the housing (piston 30 movable within the housing as discussed in paragraph [0073] and shown in Figures 1 – 3),
a holding device (patch 60, Figure 1) for receiving the microarray device (microprojection array 64) as discussed in paragraph [0073] and shown in Figure 1, wherein the holding device is connected to the housing (patch 60 is received in patch seat 56 of the housing of the device 10 as shown in Figures 1 and 7)
a pressing element (spring 40, Figure 1, paragraph [0074]) designed to displace the plunger so that the plunger acts upon the microarray device received by the holding device as discussed in paragraph [0074] and shown in Figures 1 – 3),
and an actuating device (outer cup 20, Figure 1) which holds the plunger in a first position (in the position as shown in Figure 1) and, by actuating the actuating device, releases the plunger for displacement purposes such that the plunger is moved in the direction of the microarray device so as to contact the microarray device thereby causing the microarray device to move (outer cup 20 is pressed to release catches 38 and allow spring 40 to move the piston 30 downward and impact the target site with patch 60 as discussed in paragraph [0093]),
wherein the actuating device comprises at least two separate actuators (two flexible catches 38 as shown in Figure 1),
and wherein release of the plunger by the actuating device takes place only upon a preferably cumulative actuation of the at least two actuators (actuating both flexible latches 38 as discussed in paragraph [0093]),
and wherein the cumulative actuation comprises a simultaneous actuation in which the at least two actuators are actuated at essentially the same moment (both flexible catches 38 are actuated by spring guide 22 at essentially the same moment when outer cup 20 is pressed down as discussed in paragraph [0093] and shown in Figures 1 – 3).
Regarding claim 2, Trautman teaches wherein the actuation device comprises at least one force triggering element (outer cup 20, Figure 1) such that actuation is performed when a defined force is applied (downward force to compress spring 42 as discussed in paragraph [0093]).
Regarding claim 3, Trautman teaches wherein the actuation device comprises at least one operating element (spring guide 22, Figures 1 – 3) such that the actuation takes place when it is acted upon (outer cup 20 is pressed down as discussed in paragraph [0093]).
Regarding claim 4, Trautman teaches wherein the force triggering comprises a pressing knob (outer cup 20, Figure 1).
Regarding claim 5, Trautman teaches wherein the force triggering element and an operating element (spring guide 22, Figures 1 – 3) are integrally formed with each other and are configured as a pressing knob (spring guide 22 extends from the top 23 of outer cup 20 as discussed in paragraph [0074] and shown in Figures 1 - 3).
Regarding claim 6, Trautman teaches that wherein the actuating device comprises a force-locking coupling mechanism (flexible catches 38, Figures 1 - 3) which couples the plunger to the housing in a first state (stop 18 and flexible catches 38 hold plunger 30 in the first state as shown in Figure 2) and decouples it from the housing in a second state (as shown in Figure 3) so as to allow the plunger to be displaced (see discussion of the flexible catches 38 being pressed to clear stop 18 and release the plunger 30 in paragraph [0093]).
Regarding claim 7, Trautman teaches that wherein the actuating device comprises force-locking locking mechanism (stop 18, Figures 1 - 3) which blocks the coupling mechanism in a first deactivated state (as shown in Figure 2) and unblocks it in a second activated state (as shown in Figure 3) such that the coupling mechanism can allow the plunger to be displaced (see discussion of the flexible catches 38 being pressed to clear stop 18 and release the plunger 30 in paragraph [0093]).
Regarding claim 8, Trautman teaches that a force triggering element actuates the coupling mechanism (spring guide 22 actuates/presses catches 38 as discussed in paragraph [0093]).
Regarding claim 9, Trautman teaches that an operating element actuates the coupling mechanism (spring guide 22 actuates/presses catches 38 as discussed in paragraph [0093]).
Regarding claim 10, Trautman teaches that the holding device (patch 60, Figures 1 - 3) is reversibly detachably connectable or irreversibly connectable to the microarray device (microprojection array 64, Figures 1 – 3). Examiner notes that because microprojection array 64 is disclosed to be attached to patch 60, the device as taught by Trautman reads on the current claim since the claim does not require whether the connection is reversible or irreversible.
Regarding claim 16, Trautman teaches that the operating element (spring guide 22, Figure 1) comprises a slider (spring guide 22 slide down spring seat 34 as shown in Figures 2 and 3).
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.
Claim(s) 11 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Trautman (U.S. 2005/0096586) in view of Ross (U.S. 2019/0314571).
Regarding claim 11, Trautman teaches claim 1 as seen above.
However, Trautman does not specify a protecting device which is movable relative to the holding device that in a first position shields at least a portion of the microarray device from the environment, and in a second position releases the micro array device for application purposes
Ross teaches a microneedle applicator similar to Trautman and the current application, further including a protecting device (assembly 12, Figure 1) which is movable relative to the holding device and in a first position (Figure 1A), shields at least a portion of the microarray device from the environment, and in a second position releases it for application purposes (Figure 1B) as discussed in paragraph [0063].
It would have been obvious to one having ordinary skill in the art at the time the application was filed to combine the features of Ross with the system of Trautman in order facilitate skin deformation and crowning of a portion of the skin for proper penetration of the microneedle device into the user’s skin (paragraph [0131]).
Regarding claim 12, Trautman and Ross teach claim 11 as seen above.
However, Trautman does not specify that wherein the protecting device comprises a protecting collar, wherein the protecting collar is held by a pretensioning device against a movement into the second position.
Ross teaches a microneedle applicator similar to Trautman and the current application, further including that the protecting device comprises a protecting collar (collet 22, Figure 3) wherein the protecting collar is held by pretensioning device (collet lock 50 having latching members 62 and 64, Figure 3) against a movement into the second position (as discussed in paragraph [0067]).
It would have been obvious to one having ordinary skill in the art at the time the application was filed to combine the features of Ross with the combined system of Trautman and Ross in order facilitate skin deformation and crowning of a portion of the skin for proper penetration of the microneedle device into the user’s skin (paragraph [0131]).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Trautman (U.S. 2005/0096586) in view of Kobayashi (U.S. 2016/0354589).
Regarding claim 13, Trautman teaches claim 1 as seen above.
However, Trautman does not specify a reversible or irreversible blocking device for preventing reuse of the applicator, wherein the blocking device fixes the plunger in a displaced position and/or blocks the actuation device.
Kobayashi teaches a microneedle applicator similar to Trautman and the current application, further including that irreversible blocking device for preventing reuse of the applicator, wherein the blocking device blocks the actuation device (locked the device to prevent reuse as discussed in paragraph [0446]).
It would have been obvious to one having ordinary skill in the art at the time the application was filed to combine the features of Kobayashi with the system of Trautman in order to prevent reuse of the applicator to avoid contamination (paragraph [0446]).
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 ANH T BUI whose telephone number is (571)270-1028. The examiner can normally be reached M - F 8 - 5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ANH T. BUI
Examiner
Art Unit 3783
/Anh Bui/ Examiner, Art Unit 3783
/CHELSEA E STINSON/ Supervisory Patent Examiner, Art Unit 3783