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 June 17, 2026. As directed by the amendment: claim 1 has been amended, claims 4, 10-11 and 15-17 have been cancelled, and no claims have been added. Thus, claims 1-3, 5-9, 12-14 and 18-27 are presently pending in this application.
Response to Arguments
Applicant's arguments filed June 17, 2026 have been fully considered but they are not persuasive.
On pages 10-11 of the Remarks, Applicant argues element 142 of Wirtanen with regards to the claimed access opening. In response, Examiner has not identified element 142 of Wirtanen as the access opening.
On pages 11-13 of the Remarks, Applicant argues that access opening proximal end of bore 114 of Wirtanen does not teach the claimed access opening closed off. In response, Examiner notes that Fredrickson is applied teaching container 24, wherein recess 128 of Wirtanen is closed off by container 24 of Fredrickson.
On pages 13-17 of the Remarks, Applicant argues Wirtanen does not teach the second sterile barrier. In response, Examiner agrees, having applied Frederickson to address this limitation.
On pages 18-19 of the Remarks, Applicant argues newly amended claim 1. In response, Examiner points to the rejections below.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-3, 5-9, 12-13 and 18-20 and 27 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 1 lines 24-26 recite “…wherein the combination of the first sterile barrier and the second sterile barrier are designed to completely and totally isolate therebetween the punch in the interior of the housing from the surroundings”. The written description does not support “completely and totally”. For purposes of examination, this is interpreted as “…wherein the combination of the first sterile barrier and the second sterile barrier are designed to [[Claims 2-3, 5-9, 12-13 and 18-20 and 27 are rejected at least because they depend from claim 1.
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.
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.
Claims 1-3, 5-9, 18-20 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Wirtanen et al. (Wirtanen) US 2015/0290444 A1 in view of Frederickson et al. (Frederickson) US 2010/0256568 A1.
Regarding claim 1, Wirtanen discloses a support for at least one microarray (Figs. 1-6) comprising: a punch (carrier 124, P0044) arranged in a movable manner within a housing (housing 102 and plunger 104, P0039, wherein the housing 102 is comprised of an upper portion 120 and a lower portion 122, P0043 and shown in Fig. 2); at least one microarray (microneedle array 107, P0044) connected to the punch, wherein the housing comprises an application opening (aperture 115 of skin contacting surface 112, P0041) for applying the at least one microarray; and a first sterile barrier (deformable sheet 110, P0039) for sterile storage of the at least one microarray within the housing, wherein the housing is cylindrical in shape (Figs. 1-6) and comprises an access opening (upper portion of bore 114, P0043) for accessing and moving the punch, whereby the access opening in the housing is closed off by the first sterile barrier (deformable sheet 110 extends across the upper portion of the bore 114, P0043 and Fig. 4), wherein the first sterile barrier comprises a fragile film or a flexible film (deformable sheet 110 in the form of a film, P0085) that covers the access opening, the fragile film or the flexible film being adapted so that if an action on the punch occurs, the film yields, but still ensures sterile closure of the access opening (Fig. 6), wherein the first sterile barrier is designed to close the access opening to isolate an interior of the housing (bore 114) from the surroundings (Fig. 6).
Wirtanen does not teach a second sterile barrier for sterile storage of the at least one microarray within the housing, wherein the second sterile barrier comprises a removable blister that covers the application opening, wherein the second sterile barrier is, prior to being removed, designed to close off the application opening to further isolate the interior of the housing from the surroundings, and wherein the combination of the first sterile barrier and the second sterile barrier are designed to completely and totally isolate therebetween the punch in the interior of the housing from the surroundings.
However, Frederickson teaches a microneedle cartridge assembly having a second sterile barrier (container 24, P0038) for sterile storage of the at least one microarray within the housing (container 24 helps protect the microneedle array 28 from contamination and damage prior to deployment, and can form a hermetic seal, P0038), wherein the second sterile barrier comprises a removable blister that covers the application opening, wherein the second sterile barrier is, prior to being removed, designed to close off the application opening to further isolate the interior of the housing from the surroundings (Figs. 1-3).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the support for at least one microarray of Wirtanen with the container 24 of Frederickson for the purpose of protecting the needles from contamination and damage prior to use, Frederickson P0038. The modified support of Wirtanen in view of Frederickson teaches that the combination of the first sterile barrier and the second sterile barrier are designed to completely and totally isolate therebetween the punch in the interior of the housing from the surroundings because it teaches the claimed structure.
Regarding claim 2, Wirtanen in view of Frederickson teaches the support according to claim 1, wherein the housing comprises a detachable or non-detachable connection device (Wirtanen, plunger 104, P0039) for connection to an applicator (Wirtanen, user, P0054) for moving the punch.
Regarding claim 3, Wirtanen in view of Frederickson teaches the support according to claim 2, wherein the connection device comprises: a groove; and/or a bead (Wirtanen, first and second flanges 133 and 138, P0062); and/or a thread; and/or a plug-type connection; and/or a form-fit connecting piece; and/or an adhesive join; and/or a magnetic connecting piece.
Regarding claim 5, Wirtanen in view of Frederickson teaches the support according to claim 1, wherein the housing and/or the punch is at least substantially dimensionally stable (Wirtanen, the dimensions of these elements do not substantially change with use, see Figs. 4 and 6).
Regarding claim 6, Wirtanen in view of Frederickson teaches the support according to claim 1, further comprising a release device (Wirtanen, upper thin portion 121 of first portion 120 that can flex in response to moving the plunger 104 past this thin section, P0082), between the housing and punch, wherein the release device fixes the punch in a starting position and releases it for movement upon activation (Wirtanen, force needed to move plunger 104 into the second position P2 from a starting position, P0082).
Regarding claim 7, Wirtanen in view of Frederickson teaches the support according to claim 6, wherein the release device comprises a desired-force trigger (Wirtanen, force needed to move the plunger to position P2 is determined at least in part by the width and thickness of the thin section, P0082), or a desired-force trigger with a predetermined breaking point and/or fit and/or detachable form-fit connection, wherein the desired-force trigger releases the punch for movement when at least one desired force is applied to the punch (Wirtanen, force needed to move plunger 104 into the second position P2 from a starting position, P0082).
Regarding claim 8, Wirtanen in view of Frederickson teaches the support according to claim 1, further comprising a holding device (Wirtanen, second flange 138, P0060), an engagement device, and/or snap-in device, for fixing the punch after being released.
Regarding claim 9, Wirtanen in view of Frederickson teaches the support according to claim 1, further comprising a fixing device (Wirtanen, contact adhesive 150, P0065) and/or an adhesive surface, for fixing the support to an application point.
Regarding claim 18, Wirtanen in view of Frederickson teaches the support according to claim 1, wherein the access opening is at a proximal end of the housing (Wirtanen, proximal end, see annotated Fig. 2 below, which includes proximal face of second portion 122), and wherein the first sterile barrier is connected to a proximal face at the proximal end of the housing (Wirtanen, P0043).
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Regarding claim 19, Wirtanen in view of Frederickson teaches the support according to claim 1, wherein the access opening is located on the opposite side of the punch from the at least one microarray (Wirtanen, Fig. 5).
Regarding claim 20, Wirtanen in view of Frederickson teaches the support according to claim 1, wherein the at least one microarray is connected to the punch by an adhesive layer (Wirtanen, microneedle array 107 can be coupled to the carrier 124 by adhesives, P0045).
Regarding claim 27, Wirtanen in view of Frederickson teaches the support according to claim 1, wherein the first sterile barrier completely covers the access opening (Wirtanen, deformable sheet 110 completely covers the upper portion of bore 114, P0043 and Fig. 3), wherein the punch (Wirtanen, carrier 124, P0044) has an upper proximal end (upper proximal end, see annotated Fig. 4 below) and a lower distal end (lower distal end, see annotated Fig. 4 below), and wherein the first sterile barrier further completely covers the upper proximal end of the punch (Figs. 2-4).
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Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Wirtanen in view of Frederickson in view of Panchula et al. (Panchula) US 2007/0255251 A1.
Regarding claim 12, Wirtanen in view of Frederickson teaches the support according to claim 1.
Wirtanen in view of Frederickson does not teach wherein the second sterile barrier further comprises a detachable film at the application opening.
However, Panchula et al. teaches a support for at least one microarray (microprotrusion member 44) comprising a detachable film (removable/peelable seals 50) at the application opening.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to have modified the device of Wirtanen in view of Frederickson to further include a detachable film at the application opening, as taught by Panchula et al. in order to protect the contents of the housing from contamination by gases and pollutants and water vapor for a substantial length of storage time (paragraph 37 and Fig. 4 of Panchula et al.).
Regarding claim 13, Wirtanen in view of Frederickson teaches the support according to claim 1.
Wirtanen in view of Frederickson does not teach wherein an interior of the housing and/or an interior of the blister comprises a desiccant, and/or an oxygen absorber, and/or a protective gas atmosphere.
However, Panchula et al. teaches a support for at least one microarray (microprotrusion member 44), wherein an interior of the housing comprises a protective gas atmosphere (P0037 and P0050) when modified by a seal 50, see claim 12 above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to have modified the device of Wirtanen in view of Frederickson to provide a protective gas atmosphere as taught by Panchula for the purpose of keeping out contamination, Panchula P0037.
Allowable Subject Matter
Claims 14 and 21-26 are allowed.
Reasons for Allowance
The following is an Examiner's statement of reasons for allowance: the claims in this application are allowed because the prior art of record fails to disclose either singularly or in combination the claimed support for at least one microarray.
The closest prior art is Wirtanen et al. (Wirtanen), US 2015/0290444 A1.
Regarding claim 14, Wirtanen fails to teach among all the limitations or render obvious a support for at least one microarray as claimed, which includes wherein the punch comprises a distally-directed pyramidal or conical or partially spherical punch action surface, in combination with the total structure and function of the support for at least one microarray as claimed.
Regarding claim 21, Wirtanen fails to teach among all the limitations or render obvious a support for at least one microarray as claimed, which includes wherein the punch comprises a distally-directed pyramidal or conical or partially spherical punch action surface, in combination with the total structure and function of the support for at least one microarray as claimed.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
THIS ACTION IS MADE FINAL. 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 JOHN A DOUBRAVA whose telephone number is (408)918-7561. The examiner can normally be reached M-F 9-5 Pacific Time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at 571-272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.A.D./Examiner, Art Unit 3783 /James D Ponton/Primary Examiner, Art Unit 3783
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