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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 60 and 80 on Figure 17.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 1-2 and 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Ferguson (US 2012/0263919.)
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).
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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.
Regarding claim 2, Ferguson meets the claimed, The mold unit of claim 1, wherein the first extension part is formed with a flow path (Ferguson [0083] describes the overflow channel 111 collects excess polymer thereby making it contain a flow path.)
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 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 2, 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.)
Claims 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Ferguson as applied to claim 2 above, and further in view of Zhang (CN212736739U, see English translation provided.)
Regarding claim 3, Ferguson does not describe a container and does not meet the claimed, The mold unit of claim 2, further comprising 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, 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 2, further comprising 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, 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 page 6 lines 1-8 describe a bottom cover to a mold frame 2 which has an inner space and an open upper surface, see Figure 2. 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 3 lines 20-24.
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 6 lines 33-34 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 6 lines 33-25.
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 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 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 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 first 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 flow path is 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
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 2009/0234301: see Figure 7 and the accompanying description beginning at [0057] which describes a mold 63 having needle forming portions 66, the mold shown in Figure 7A has a slightly elevated portion similar to the claimed embankment and a frame (edge) 62 around the needle forming portions
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VICTORIA BARTLETT whose telephone number is (571)272-4953. The examiner can normally be reached Monday - Friday 9:00 am-5:00 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sam Zhao can be reached at 571-270-5343. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/V.B./Examiner, Art Unit 1744
/XIAO S ZHAO/Supervisory Patent Examiner, Art Unit 1744