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
The objections to the drawings are withdrawn in response to the amendments to the specification filed 4/2/2026.
Applicant's arguments filed 4/2/2026 have been fully considered but they are not persuasive.
Applicant argues that Ferguson and Zhang do not disclose the amended limitation of claim 1 regarding the composition flowing through the extension part and flow paths into the storage container. Examiner disagrees and notes that this is the intended use of the apparatus and that the rejection is based on the combination of references, not individual references. Ferguson describes two flow paths and an extension part. These components are specifically configured for addressing overflowing mold material, see Ferguson [0083]. While Ferguson does not disclose a container beneath the mold, Zheng does disclose a bottom mold cover 2 in the claimed container shape which sits below mold body 1. While neither Ferguson nor Zheng explicitly disclose that the molding material would overflow into the storage container, when Ferguson is combined with the storage container of Zheng, the mold is capable of flow overflowing material into the overflow channel 111 via the sides (flow paths) and then again over the primary vent 113 into the vent 116 which vents outside the mold and into the mold cover 2 of Zheng below, see Ferguson [0083] describing the overflow mechanisms. Since there is no particular structure imparted by this limitation, the claim is not patentably distinct from the combination of Ferguson and Zheng. Examiner suggests amending the claims to claim particular structural details of the flow paths, how the flow paths connect to the storage container, etc.
Claim Objections
Claim 9 objected to because of the following informalities:
Claim 9 contains a small typographical error and should read “…the plurality of flow paths is formed toward the region…” or something similar.
Appropriate correction is required.
Claim Interpretation
Some claims, such as claim 1, include the intended use of the apparatus. Recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the case of claim 1, the composition introduced into the first extension part flowing into the interior of the storage container is the intended use of the apparatus. The structure is not particularly limited by this limitation other than the mold must be capable of flowing a composition into a storage part via the flow paths. Examiner suggests amending the claim such that there is a structural limitation regarding how the flow paths connect to the storage container.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3-4, and 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Ferguson (US 2012/0263919) modified by Zhang (CN212736739U, see English translation provided.)
Regarding claim 1, Ferguson meets the claimed, A mold unit for manufacturing microstructures, the mold unit comprising a first mold for manufacturing microstructures in which a plurality of microneedles are formed on one surface of a base layer, (Ferguson [0083] and Figure 15 describe a mold with microcavities 39 for microneedles, see also [0064]) wherein the first mold includes: a first base part (Ferguson [0064] describes the insert 38 with the microcavities 39 which are also present in Figure 15) in which first needle grooves for forming the microneedles are formed on an upper surface of the first mold, (Ferguson Figure 15 shows the micro-cavities 39 on the upper surface of the insert 38) and which includes a first embankment protruding with a predetermined height around a region in which the first needle grooves are formed; (Ferguson [0083] describes the overflow gate 110) a first edge part which is provided along a periphery of the first base part while being spaced apart from the first base part at a predetermined distance, (Ferguson [0083] describes primary vent 113 which is spaced apart from the insert 38) and in which an upper end of the first edge part is provided higher than the first embankment; (Ferguson Figure 15 shows the primary vent 113 is higher than the overflow gate 110) and a first extension part which extends from the first base part to the first edge part, (Ferguson [0083] and Figure 15 describe overflow channel 111) wherein a plurality of flow paths are formed in the first extension part so as to be spaced apart from one another along a periphery thereof, (Ferguson Figure 15 shows two inclined flow paths, one on either side of the outflow channel 111.)
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Ferguson does not explicitly show or describe the overflow channel 111 as being lower than any region where the needle grooves are formed and does not explicitly meet the claimed, and in which an upper surface of the first extension part is positioned lower than the region in which the first needle grooves are formed, however Ferguson [0083] notes the depth of the overflow channel, among other dimensions, is within the skill of the art. Therefore, it would be obvious to a person of skill in the art to make the overflow channel 111 deeper and thereby lower than the region with the needle grooves for the purpose of holding more overflow.
Ferguson does not describe a container and does not meet the claimed, and a storage container having an inner space with an open upper surface, in which a lower end of the first edge part is disposed on an upper end of the storage container, and wherein a composition introduced into the first extension part flows into an interior of the storage container through the plurality of flow paths.
Analogous in the field of micro-scale molds, Zhang meets the claimed, and a storage container having an inner space with an open upper surface, in which a lower end of the first edge part is disposed on an upper end of the storage container (Zhang Figure 2 shows a bottom cover to a mold frame 2 which has an inner space and an open upper surface, see Zhang page 7 lines 31-39) and wherein a composition introduced into the first extension part flows into an interior of the storage container through the plurality of flow paths (Zhang Figure 2 and Zhang page 7 lines 31-39 and page 7 line 41- page 8 line 19 describe how the mold body 1 is situated on the mold frame 2 such that it would be possible for silicone molding material to overflow into the mold body 2. When the bottom mold cover 2 is combined with the mold of Ferguson, it would be possible to add enough molding composition such that the molding composition overflows into the extension part, outflow channel 111, and out through the vent 116 into the container, mol cover 2 below.)
It would have been obvious to a person of ordinary skill in the art before the filing date to combine the mold of Ferguson with the bottom cover of Zhang to prevent dust or impurities from entering the mold, see Zhang page 4 lines 1-6.
Regarding claim 3, Ferguson does not describe a container and does not meet the claimed, The mold unit of claim 1, wherein a bottom surface of the storage container is spaced apart from a lower surface of the first base part at a predetermined distance.
Analogous in the field of micro-scale molds, Zhang meets the claimed, The mold unit of claim 1, wherein a bottom surface of the storage container is spaced apart from a lower surface of the first base part at a predetermined distance (Zhang Figure 2 shows a bottom cover to a mold frame 2 where the bottom is spaced apart from the pinhole array 111 via the convex surface 21.)
It would have been obvious to a person of ordinary skill in the art before the filing date to combine the mold of Ferguson with the bottom cover of Zhang to prevent dust or impurities from entering the mold, see Zhang page 4 lines 1-6.
Regarding claim 4, Zhang further meets the claimed, The mold unit of claim 3, wherein the storage container is separable from the first mold (Zhang page 7 lines 21-29 describe the mold body 1 is separable from the bottom mold frame 2.)
It would have been obvious to a person of ordinary skill in the art before the filing date to combine the mold of Ferguson with the container of Zhang being separable as in order to remove the molded body from the mold, see Zhang page 7 lines 21-29.
Regarding claim 6, Ferguson meets the claimed, The mold unit of claim 1, wherein one side surface of the embankment, which is adjacent to the region formed with the first needle grooves, is provided as an inclined surface (Ferguson Figure 15 shows the inclined surface of the overflow gate 110.)
Regarding claim 7, The mold unit of claim 1, wherein the flow path extends from the upper surface of the first extension part, and is inclined downward toward a center of the first base part (Ferguson Figure 15 shows the inclined portion, see labeled Figure 15 above.)
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Ferguson modified by Zhang as applied to claim 3 above, and further in view of Kulik (US 2022/0062604.)
Regarding claim 5, neither Ferguson nor Zhang describe The mold unit of claim 3, wherein the bottom surface of the storage container is formed with an opening, and wherein the mold unit further comprises a valve for opening/closing the opening.
Analogous in the field of microneedle molds, Kulik meets the claimed, The mold unit of claim 3, wherein the bottom surface of the storage container is formed with an opening, and wherein the mold unit further comprises a valve for opening/closing the opening (Kulik [0035] and [0038] describe a filling connection 46 on a subshell 41. The subshell 41 acts as a container beneath the microneedle mold 21. The filling connection 46 is an opening and [0035] and [0038] describe it can be closed with a syringe which meets the broadest reasonable interpretation of a valve.)
It would have been obvious to a person of ordinary skill in the art before the filing date to combine the container described in Ferguson as modified by Zhang with the filling connection opening and syringe as described in Kulik in order to store the filling material, see Kulik [0043].
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Ferguson modified by Zhang and in further view of Bratton (US 2015/0001761.)
Regarding claim 8, Ferguson previously describes a mold meeting all the limitations, wherein the second mold includes: a second base part in which second needle grooves(Ferguson [0083] and Figure 15 describe a mold with microcavities 39 for microneedles, see also [0064]) for forming the microneedles are formed on an upper surface of the second mold, (Ferguson Figure 15 shows the micro-cavities 39 on the upper surface of the insert 38) and which includes a second embankment protruding with a predetermined height around a region in which the second needle grooves are formed; (Ferguson [0083] describes the overflow gate 110 and Figure 15 shoes it protrudes above the needle cavities) a second edge part which is provided along a periphery of the second base part while being spaced apart from the second base part at a predetermined distance, (Ferguson [0083] describes primary vent 113 which is spaced apart from the insert 38) and in which an upper end of the second edge part is provided higher than the second embankment; (Ferguson Figure 15 shows the primary vent 113 is higher than the overflow gate 110) and a second extension part which extends from the second base part to the second edge part, (Ferguson [0083] and Figure 15 describe overflow channel 111) and in which an upper surface of the second extension part is positioned lower than the region in which the second needle grooves are formed (Ferguson [0083] notes the depth of the overflow channel, among other dimensions, is within the skill of the art.)
Ferguson does not teach a stacked mold configuration and does not meet the claimed, The mold unit of claim 7, further comprising a second mold that is stackable with the first mold,
Analogous in the field of molds and mold frames, Bratton describes a mold that has a similar structure to the claimed mold. Bratton describes a main mold 24, with a cavity 17, a top face (embankment) 13 around the cavity, and a frame 21 (edge) having flanges extending upwards. Bratton meets the claimed, The mold unit of claim 7, further comprising a second mold that is stackable with the first mold (Bratton [0060]-[0061] describe a main mold 24 which is inserted into a mold frame 21 and then stacked on top of other molds.)
It would have been obvious to a person of ordinary skill in the art before the filing date to simply duplicate the existing mold of Ferguson and stack them on one another in the manner described in Bratton in order to produce many molded articles at a time in a limited amount of space, see Bratton [0001] and [0010].
Regarding claim 9, Ferguson meets the claimed, The mold unit of claim 8, wherein the plurality of flow paths formed toward the region in which the second needle grooves are formed in the second base part (Ferguson Figure 15 shows how the flow path area of the overflow channel 111 points down towards a second mold in the stacking configuration described above.)
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.
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/V.B./Examiner, Art Unit 1744
/XIAO S ZHAO/Supervisory Patent Examiner, Art Unit 1744
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