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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 January 27, 2026 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on January 27, 2026. As directed by the amendment: claims 1, 8, 13-14, 21 and 25 have been amended, claims 4, 10-11 and 15-17 have been cancelled, and claim 27 has been added. Thus, claims 1-3, 5-9, 12-14 and 18-27 are presently pending in this application. Applicant’s amendments are sufficient to overcome the §112(b) rejections of the previous action.
Response to Arguments
Applicant’s arguments, see Remarks, filed January 27, 2026, with respect to the rejection of newly amended claim 1 under 35 U.S.C. §103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new grounds of rejection is made in view of Frederickson et al. (Frederickson) US 2010/0256568 A1.
On page 9 of the Remarks, Applicant summarizes some of the arguments related to Wirtanen by stating that the proximal end of bore 114 closed by deformable sheet 110, as cited by the Examiner in the previous action, is not equivalent to the access opening.
On page 9 of the Remarks, Applicant argues that Wirtanen fails to discloses the claimed first sterile barrier. Examiner has mapped the first sterile barrier to the deformable sheet 110 of Wirtanen, see below.
On page 10 of the Remarks, Applicant asserts that the access opening is opening 142 of Wirtanen. In response, Examiner notes that the access opening has not been mapped to opening 142 of Wirtanen in the previous action, but instead to the upper portion of bore 114, wherein the deformable sheet 110 closes the upper portion of bore 114 thereby isolating the bore 114 from the surroundings, wherein bore 114 is an interior of the housing.
On pages 10-11, Applicant argues that Wirtanen does not teach the lower pocket/recess 128 as closed off. In response, Examiner notes that P0049 of Wirtanen references the bore 114 and the pocket/recess 128 to be the same structures, and this is also shown in Fig. 3. Claim 1 lines 7-8 recites “…the access opening…is closed off by the first sterile barrier…”, which is taught by Wirtanen, see below.
On page 11, Applicant argues that deformable sheet 110 of Wirtanen fails to close off the opening formed by aperture 142. In response, Examiner notes claim 1 lines 7-8 recites “…the access opening…is closed off by the first sterile barrier…”, wherein the access opening is not mapped to aperture 142, see above.
On page 15 of the Remarks, to the best of Examiner’s understanding, Applicant argues that the “access opening” must be interpreted as the opening formed by aperture 142 because it is the most proximal opening. In response, Examiner notes that claims must be given their broadest reasonable interpretation in light of the specification (MPEP 2111), wherein access opening must be interpreted consistently with the ordinary and customary meaning of the term, consistent with the claim term in the specification and drawings. The ordinary and customary meaning of access opening does not include a most proximal opening, and the access opening of Wirtanen mapped below is consistent with the access opening 28 of Applicant’s device shown in Applicant’s drawings, wherein Applicant’s device lacks additional structure taught by Wirtanen including aperture 142 for guiding a plunger.
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 wherein a second sterile barrier comprises a removable blister that covers the application opening, and wherein the second sterile barrier is, prior to being removed, designed to close the application opening to further isolate the interior of the housing from the surroundings, wherein the punch and the at least one microarray are completely and totally located between and enclosed by the combination of the housing, the first sterile barrier, and the second sterile barrier.
However, Frederickson teaches a microneedle cartridge assembly having a second sterile barrier (container 24, P0038) that comprises a removable blister that covers the application opening (Figs. 1-3), and wherein the second sterile barrier is, prior to being removed, designed to close the application opening to further isolate the interior of the housing from the surroundings (container 24 helps protect the microneedle array 28 from contamination and damage prior to deployment, P0038).
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 the punch and the at least one microarray (Wirtanen, microneedle array assembly 106, P0044) completely and totally located between and enclosed by the combination of the housing 122 of Wirtanen, the first sterile barrier 110 of Wirtanen, and the second sterile barrier 24 of Frederickson (prior to use and removal of the second sterile barrier, the microneedle array assembly 106 is covered by the deformable sheet 110 of Wirtanen and surrounded by the bore 114 of Wirtanen, see Fig. 3 of Wirtanen, and the microneedle array assembly 106 of Wirtanen is enclosed by the container of Wirtanen in view of Frederickson).
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
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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/J.A.D./Examiner, Art Unit 3783 /James D Ponton/Primary Examiner, Art Unit 3783