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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/10/2024. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 9 is objected to because of the following informalities: the phrase “the polymer resin material” in lines 2-3 should be amended to read –the polymer resin--. Appropriate correction is required.
Claim 17 is objected to because of the following informalities: the phrase “an adapter’ in line 3 should be amended to read –the adapter--. Appropriate correction is required.
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.
Claims 6-8, 11, 17 and 18 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 6 recites the limitation "the closed bottom" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation "the closed bottom" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation "the open top" in lines 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation "the centrifuge" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 17 recites the limitation "the adapters" in line 1. There is insufficient antecedent basis for this limitation in the claim.
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.
Claim(s) 1-7, 12-15, 20 and 35 is/are rejected under 35 U.S.C. 103 as being obvious over Yamada et al (US 2017/0348880), in view of Liu et al (US 2020/0054869).
As to claim 1-4, 20 and 35, Yamada teaches a mold for making a plurality of microneedle arrays (MNAs) (mold 80 for making microneedle array 110, par.54 par.63-65, fig.1 and 5), comprising:
a tray (the body of mold 80, as best seen in fig.5) comprising a top surface (surface 82, par.64, fig.5), a bottom surface (adjacent/opposite surface from top surface 82, fig.5), and a sidewall (the side walls between top and bottom surface, a best seen in fig.5, par.63-66) extending between the top surface and the bottom surface;
a plurality of wells (recesses 81, on top surface 82, as best seen in fig.5 and 7-8, par.63-65 and par.73-75) on the top surface of the tray, each well comprising an open top (open top that receives raw-material liquid 91, as best seen in fig.5 and 7-8, par.63-65 and par.73-75), a closed bottom (closed bottom of recesses 81 that forms the tip of the microneedle, as best see i fig.7-8), and an inner surface extending between the open top and the closed bottom (inner surface between open and closed end of 81, as best seen in fig.7-10); and
a plurality of fiducial markers (alignment marks 83 are formed on the surface 82 of the mold 80, par.64, fig.5) on the tray that can be identified in images of the mold captured by optical sensors for aligning the mold with a dispenser of an MNA manufacturing system (alignment marks 83 are read by the CCD camera 22 of the microneedle-array manufacturing apparatus, the position of each recessed part 81 is determined using the alignment marks 83 as a reference, par.64, alignment is performed by the CCD camera 22 taking images of the alignment marks 83 on the mold 80 on the XYZ stage 21 and by the control apparatus 30 performing recognition using the alignment marks 83 as a reference, par.72-74, fig.1 and 5),
dispensing a polymer resin into the plurality of wells, comprising a at least one dispensing nozzle (dispensing raw material/resin 91 into recess 81 using nozzle 11a, par.53 and par.66, fig.1 and 8); curing and solidifying/drying the polymer resin (step5 and step 15 in fig.6, par.77-80); removing individual molded MNA parts from the at least one mold with at least one electromechanical mover controlled by at least one computer processor and assembling the plurality of MNA from the molded MNA parts with the at least one electromechanical mover (at the end point of the belt conveyor, in the state in which the peak-part-layer, raw-material liquid 91 has dried and solidified, the molds 80 are successively removed and moved to the next step, which is the combining using sterilized robot arm, par.77 and par.80-81).
Still regarding claims 1-4, 20 and 35, Yamada teaches the invention substantially as claimed above, but failed to explicitly teach centrifuging the at least one mold to distribute the dispensed polymer resin within the plurality of wells of the at least one mold. However, Liu teaches an analogous microneedle array manufacturing (abstract, par.52-54, fig.1-6), wherein centrifuging the at least one mold to distribute the dispensed polymer resin within the plurality of wells of the at least one mold (he casting process can utilize centrifugal force or a similar technique to force the first HA polymer solution or the second HA polymer solution deeper into the elongate wells of the microneedle array mold, par.111 and par.124).
Since centrifuging the mold in microneedle manufacturing process is well-known in the art, so it would have been obvious to one having an ordinary skill in the art before the effective filing date of the invention to centrifuge mold 80 taught by Yamada’s invention, as taught by Liu’s invention, for the same purpose of forcing the raw material/ polymer solution to go deeper into the elongate wells of the microneedle array mold, as taught by Liu’s invention (par.111 and par.124).
As to claim 5, Yamada/ Liu combination teaches the invention substantially as claimed above wherein the mold have a plurality of wells with specific dimensions (par.56-58), but failed to explicitly teach the tray comprises 96 wells and corresponds in size (e.g., length and width) to a standard 96 well tray used for biological sampling.
However, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or working ranges involves only routine skill in the art, In re Aller, 105 USPQ 233. And/or it would have been considered an obvious matter of design choice to a person of ordinary skill in the art at the time the invention was made, because the Applicant has not disclosed that these specific dimensions provide an advantage, is used for a particular purpose, or solves a stated problem.
As to claim 6, Yamada teaches the method, wherein the at least one mold further comprises at least one hole on the closed bottom of the plurality of wells for forming microneedles of the MNAs (closed bottom of recesses 81 that forms the tip of the microneedle, as best seen in fig.7-8).
As to claim 7, Yamada teaches the method, wherein a bottom portion of the at least one hole is tapered for forming a sharpened needle tip of the microneedles (closed tapered bottom of recesses 81 that forms the tip of the microneedle, as best see i fig.7-8).
As to claim 12, Yamada teaches the method, wherein the polymer resin is dispensed into a well of the plurality of wells through a multi-head nozzle having two, three, four, or more heads configured to distribute the polymer resin throughout the well of the plurality of wells (embodiments in fig. 10 and 16 has multiple nozzles, par.94-96 and par.115). It would have been obvious to use multiple nozzle head in the first embodiment in fig.1 taught by Yamada’s invention, as taught in the other embodiments in fig.10 and 16.
As to claim 13, Yamada in view of Liu teaches the method, wherein the dispensing, centrifuging, and curing steps are repeated multiple times to provide a multi-layer MNA (repeating steps in fig.6, par.70-par.82).
As to claims 14 and 15, Yamada teaches the method, further comprising obtaining images of assembled MNAs with at least one optical sensor and analyzing the obtained images with the at least one computer processor to identify defects in the assembled MNAs, and further comprising removing any MNAs with identified defects from a group of assembled MNAs (camera 22 takes imaged during the whole process and inherently will detect any defects, and implicitly the system/manually the defected MNA will be removed, apr.70-82).
Allowable Subject Matter
Claims 8-11 and 17-19 would be allowable if rewritten 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 and to include all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAY A ABOUELELA whose telephone number is (571)270-7917. The examiner can normally be reached 8-5.
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/MAY A ABOUELELA/Primary Examiner, Art Unit 3791