DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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 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.
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 3-5 is 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.
Regarding claim 3:
The claim is unclear because of limitation “a first ink and a second ink” in line 2. This limitation is unclear because a structure of “ink” in line 4 of claim 1 (on which this claim depends) which raises a question of are there two different inks required by claim 3 or three. For the sake of examination, the office has interpreted the ink of claim 1 to include the first and second ink of claim 3. However, the applicant should amend the claim to clarify.
Claims 4-5 are rejected due to their dependence on claim 3.
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) 1-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20180140815 A1 to Ono et al. (Ono) in view of US 20120105528 A1 to Alleyne et al. (Alleyne).
Regarding claim 1:
Ono discloses:
A microneedle manufacturing apparatus using electrohydrodynamic printing (teaches the structure as required by the claim), the microneedle manufacturing apparatus (see figures 1 and 23) comprising:
a substrate (101/120 or 200) on which a printed microneedle (104/106/105) is placed;
a nozzle unit (11a) receiving a base material (13a), which is a biocompatible material (see ¶0070 which indicates 104/105/106 can be a “biologically active medicinal substance” or biocompatible material), as ink (see ink drops 91a-91e as shown in figure 8) and discharging the ink to the substrate (200);
a controller (30) controlling the ink is dropped from the nozzle unit (see the figure 2 which shows how the controller controls the nozzle/discharge head).
Ono fails to disclose:
A power unit supplying power to the nozzle unit.
Alleyne teaches:
An electrohydrodynamic printing system (figure 2a) that includes a nozzle (30/70/20), a substrate (120), power unit (50) and controller (40). The power unit controls the power supplied to the nozzle and controlled by the controller (¶0149).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ono to include a power unit as taught by Alleyne to control the amount of power supplied to the nozzle (Alleyne, ¶0149). Further, Ono fails to describe how power is delivered to the system for controlling the nozzle and Alleyne provides a power supply for controlling the system.
Regarding claim 2:
Ono discloses:
The microneedle manufacturing apparatus of claim 1, further comprising a curing unit (see ¶0081, “penetration promoting means”) curing the microneedle placed on the substrate (as indicated in ¶00081).
Regarding claim 3:
Ono discloses:
The microneedle manufacturing apparatus of claim 1, wherein
the nozzle unit (11a) sequentially discharges a first ink (see figure 10 with ink 91) and a second ink (see figure 10 with ink 93), which are different base materials (¶0094), to the substrate (200/21), and
the microneedle is formed in a multilayer structure (see the multilayer structure as shown in figure 15a or in figure 23) on the substrate (200).
Regarding claim 4:
Ono fails to disclose:
The microneedle manufacturing apparatus of claim 3, wherein
the controller (30) controls voltage and waveform of the power unit depending on physical properties of the first ink and the second ink.
Alleyne teaches:
An electrohydrodynamic printing system as shown in figure 2b that includes a controller (800/40) that includes power unit (50) that controls the operation of the nozzle based on the physical properties of the ink and other factors (see ¶0054, 0064, 0015). A voltage/waveform (900 as shown in figure 2b) is emitted by the power unit to control the ink of the nozzle.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ono to replace the nozzle, controller and power unit of Ono with the nozzle and controller as taught by Alleyne. This is a simple substitution of one known element (controller and nozzle of Ono) for another (controller and nozzle of Alleyne) to obtain predictable results (to print the ink of the microneedle onto the substrate). This would result in multiple nozzle for different inks as required by Ono and controlling those nozzles/power units/controllers with different waveforms/voltages based on the properties of the different inks emitted as taught by Alleyne (see Alleyne, ¶0054, 0064, 0015).
Regarding claim 5:
Ono fails to disclose:
The microneedle manufacturing apparatus of claim 3, wherein
an electric field is formed between the nozzle unit and the substrate, and
an electric field formed when the first ink is dropped from the nozzle unit and an electric field formed when the second ink is dropped from the nozzle unit are set differently.
Alleyne teaches:
An electrohydrodynamic printing system (figure 2a) that includes a nozzle (30/70/20), a substrate (120), power unit (50) and controller (40). The power unit controls the power supplied to the nozzle and controlled by the controller (¶0149). The system further includes forming an electric field between the nozzle and the substrate (¶0019, 0133, 0138, 0140).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ono to replace the nozzle, controller and power unit with the nozzle, controller and power unit as taught by Alleyne. This is a simple substitution of one known element (nozzle, controller and power unit of Ono) for another (nozzle, controller and power unit as taught by Alleyne) to obtain predictable results (to print the ink/“biologically active medicinal substance”/biocompatible material). This would add a nozzle unit with an electric field between the nozzle and substrate for injecting ink/“biologically active medicinal substance”/biocompatible material onto the substrate and further would have two different electric fields between the two different nozzles (11a and 11b or Ono) for the different inks (91 and 93) since they are different compositional and since Alleyne indicates that the electric field is formed based on the ink material and other factors (Alleyne, ¶0053, 0064 and 0115).
Regarding claim 6:
Ono discloses:
The microneedle manufacturing apparatus of claim 1, further comprising
an image acquisition unit (22) photographing the ink dropped from the nozzle unit (11a)(¶0090).
Regarding claim 7:
Ono discloses:
A microneedle manufacturing method using electrohydrodynamic printing, the microneedle manufacturing method comprising:
supplying ink (see ink drops 91a-91e as shown in figure 8), which is a biocompatible material (see ¶0070 which indicates 104/105/106 can be a “biologically active medicinal substance” or biocompatible material), to the nozzle unit (11a); and
forming a microneedle (104/106/105) in a height direction of the substrate (200) by dropping the ink (91/91-91e as shown in figure 8) from the nozzle unit (11a) onto the substrate (200).
Ono fails to disclose:
Forming an electric field between a nozzle unit and a substrate.
Alleyne teaches:
An electrohydrodynamic printing system (figure 2a) that includes a nozzle (30/70/20), a substrate (120), power unit (50) and controller (40). The power unit controls the power supplied to the nozzle and controlled by the controller (¶0149). The system further includes forming an electric field between the nozzle and the substrate (¶0019, 0133, 0138, 0140).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ono to replace the nozzle, controller and power unit with the nozzle, controller and power unit as taught by Alleyne. This is a simple substitution of one known element (nozzle, controller and power unit of Ono) for another (nozzle, controller and power unit as taught by Alleyne) to obtain predictable results (to print the ink/“biologically active medicinal substance”/biocompatible material). This would add a nozzle unit with an electric field between the nozzle and substrate for injecting ink/“biologically active medicinal substance”/biocompatible material onto the substrate.
Regarding claim 8:
Ono discloses:
The microneedle manufacturing method of claim 7, wherein in forming the microneedle in the height direction of the substrate (200),
a controller (30) adjusts a position of the substrate (200) or the nozzle unit (11a) or an electric field between the nozzle unit (11a) and the substrate (200), so that a sharp tip of the microneedle is placed the farthest away from a surface of the substrate (200)(as shown in figure 23, the nozzle unit prints the microneedle in a manner where the tip is the furthest point from the top surface of the substrate 300/200) .
Allowable Subject Matter
Claims 9 and 10 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The following is pertinent prior art:
US-20220305736-A1
Praharaj
See the microneedles as shown in figure 3
US-20090016935-A1
Andrianov
See the microneedles as shown in figure 6
US-20170197360-A1
Batchelder
See the electrohydrodynamic system as shown in figure 1
US-10913201-B2
Kuk
See the nozzle 2/3/4
WO-2019198936-A1
LEE
See the microneedles as shown in figure 2c
KR-20220001500-A
LEE
See the micro needle 200
CN-114103102-A
LI
See the nozzle 10 in figure 1
WO-2015103524-A1
MULLER
See the nozzle in the ink jet 200
WO-2015200201-A1
ROLLAND
See the printer system 14
WO-2019094349-A1
CHANG
See the microneedle 1c
WO-2016098780-A1
ONO
See the system as shown in figure 1
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WESLEY HARRIS whose telephone number is (571)272-3665. The examiner can normally be reached M to F, 9am-5pm.
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/WESLEY G HARRIS/Examiner, Art Unit 3783