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 Arguments
Applicant’s arguments, see Remarks, filed 01/02/2026, with respect to the rejection(s) of claim(s) 1-6, 8-10, and 13-14 under 35 U.S.C. 102 and 35 U.S.C. 103 have been fully considered.
Regarding claims 1-6, 8-10 and 13-14, the applicant contends that:
“Turning to Hwang, this piece of art discloses a method for manufacturing a microneedle containing a coating part on a needle tip and an apparatus used for the method, where a microneedle is manufactured using the coating method and apparatus. Also disclosed is a coating part in which a target material is impregnated and can be easily inserted into skin and effective dissolution is possible. Further disclosed is a target material that is allowed to show excellent skin permeability with the dissolution of the coating part of the microneedle manufactured according to the present disclosure, thereby a quantitative amount of target material can be effectively delivered into the skin.
Given the disclosure contained therein, while Hwang does disclose some form of a cover element (see masking film / second layer in Paragraph [0013] of Hwang), the invention of Hwang differs from the present invention as recited in pending claim 1 for at least the following reasons.
As described at paragraph [0026] of Hwang, the masking film in the form of the "second layer" as shown in Figure 2 thereof is only applied to the very top surface of the "first layer" mold that is used to form the microneedles. As would be able to be determined by one of skill in the art, the cavities of the first layer mold in Hwang are then filled such that the formulation surpasses the cavities and the second layer (see Figure 3). Next, the cavities (the "first layer" mold) are removed first, leaving the formed microneedles with the "second layer" mask portion attached to the microneedles (see Figure 4). Such a "second layer" then serves as a "masking" to mask the foundation of the microneedles, such that only the tip of the thus-formed needles can be coated (see Figure 5). Accordingly, as would be apparent to those of skill in the art, Hwang relates to a technology that differs significantly from that of the present invention.”
The examiner respectfully disagrees. The masking layer that meets the limitation of a cover element could be used in the manner claimed. It is well settled that the intended use of a claimed apparatus is not germane to the issue of the patentability of the claimed structure. If the prior art structure is capable of performing the claimed use then it meets the claim. In re Casey, 152 USPQ 235, 238 (CCPA 1967); In re Otto, 136 USPQ 459 (CCPA 1963).
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 11 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 11 recites the limitation "a cover element" in line 12. There is insufficient antecedent basis for this limitation in the claim. The claim previously recites “a cover element” in line 4 and subsequently refers to “the cover element” in line 5. Therefore, it is unclear as to whether the cover element referenced in line 12 is a different cover element or the one previously referenced in the claim.
Appropriate correction is required.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-6, 8, 10, and 13-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hwang (US20200324096A1 corresponding to WO2019103268 of record).
Regarding claims 1 and 14, Hwang teaches an apparatus for producing microarrays (ABS), having a die comprising a plurality of cavities (P0013, engraved patterns, fig.1, mold), and a cover element which covers regions between the cavities (P0013, masking film). Hwang teaches the cover element comprises projections which protrude into the cavities (fig.3). Hwang further shows the masking film (second layer, fig.1-4) covering regions between microneedle cavities and then being removed before the final step.
While Hwang doesn’t specifically teach the cover element is intended to cover regions between cavities while active agent-containing material is metered into the cavities and then removed after this, the claim is directed to an apparatus and as such the material worked upon or the process of using the apparatus are viewed as recitation of intended use and are given no patentable weight (Please see MPEP 2114 R1-2115 R2 for further details). Further, if the prior art structure is capable of performing the claimed use then it meets the claim. In re Casey, 152 USPQ 235, 238 (CCPA 1967); In re Otto, 136 USPQ 459 (CCPA 1963).
Regarding claims 2 and 13, Hwang teaches the die comprises an upper surface on which the openings of the cavities are formed (fig.1, P0013).
While Hwang doesn’t specifically teach the cover element is intended to cover regions between cavities while active agent-containing material is metered into the cavities, the claim is directed to an apparatus and as such the material worked upon or the process of using the apparatus are viewed as recitation of intended use and are given no patentable weight (Please see MPEP 2114 R1-2115 R2 for further details). Further, if the prior art structure is capable of performing the claimed use then it meets the claim. In re Casey, 152 USPQ 235, 238 (CCPA 1967); In re Otto, 136 USPQ 459 (CCPA 1963).
Regarding claim 3, Hwang teaches the cover element rests on the upper surface on which the openings of the cavities are formed (fig.3).
Regarding claim 4, Hwang teaches the cover element is removable (fig.4).
Regarding claim 5, Hwang teaches the cover element is formed as a foil.
Regarding claim 6, Hwang teaches the cover element is formed as a template (P0026).
Regarding claim 8, Hwang teaches the projections rest on inside walls of the cavities, in an upper region of the cavities (fig3).
Regarding claim 10, Hwang teaches the upper region of the cavities is entirely covered by projections (fig.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.
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.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Hwang (US20200324096A1 corresponding to WO2019103268 of record) as applied to claim 1.
Regarding claim 9, Hwang teaches the projections are formed as a solid shape (fig.3) and not peripherally in the manner of a collar. However, it has been held that a mere change in shape without affecting the functioning of the part would have been within the level of ordinary skill in the art, In re Dailey et al., 149 USPQ 47; Eskimo Pie Corp. v, Levous et aI., 3 USPQ 23.
Allowable Subject Matter
Claims 11 and 12 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter: Claims 11 and 12, directed to a method for producing a microarray are allowable as the closest prior art of record, Hwang (US20200324096A1 corresponding to WO2019103268 of record), does not anticipate or render obvious the limitations of “metering active agent-containing liquid into the cavities; removing the cover element; and metering an active agent-free liquid into the cavities and onto an upper surface of the die for creating a support layer of the microarray” as claimed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Erica Funk whose telephone number is (571)272-3785. The examiner can normally be reached on Monday - Friday 8:00am-5:00pm.
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/ERICA HARTSELL FUNK/Examiner, Art Unit 1741