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 Objections
Claim 1 is objected to because of the following informalities: line 1 should be amended to -A device for producing microneedles, comprising: a microneedle female mold, a vacuum chamber-. Appropriate correction is required.
Claim 25 is objected to because of the following informalities: line 3 should be amended to - wherein microneedle female molds of different sizes can be transported-. 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 4, 6-8, 13-15, 21, 25 and 27 are 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 4:
The claim recites the limitation "the respective cavities" in the final line. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 6:
The claim recites the limitation "the cavities" in the final line. There is insufficient antecedent basis for this limitation in the claim.
Claims 7-8 are rejected due to their dependence on claim 6.
Regarding claim 8:
The claim limitation “there are at least three press blocks;” in line 3 is unclear. The structure of the press blocks was already added in line 3 of the claim and this limitation raises a question of if there are additional press blocks or if this is further modifying the press blocks established in line 2. For the sake of examination, the office has assumed that this is further modifying the press blocks of line 2 however the applicant should amend the claim to clarify.
Regarding claim 13:
The claim recites the limitation "the empty tray" in the line 6. There is insufficient antecedent basis for this limitation in the claim.
Claims 14-15 are rejected due to their dependence on claim 13.
Regarding claim 21:
The claim limitation “a leveling process” in the final line is unclear. The limitation is unclear since a leveling process has already been established in line 10 of claim 20 (on which this claim depends) raising a question of if multiple leveling processes are required by claim 21 or if these limitations all refer to the same leveling process. For the sake of examination, the office has assumed that they all refer to the same leveling process however the applicant should amend the claim to clarify.
Regarding claim 25:
The claim recites the limitation "the empty tray" in the line 7. There is insufficient antecedent basis for this limitation in the claim.
Claim 27 is rejected due to its dependence on claim 25.
Regarding claim 27:
The claim recites the limitation "the tray" in the line 11. 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) 1-3, 5, 12, 20-21, 23 and 32-34 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20160038729 A1 to Kato in view of CN 203242709 U to Liu et al. (Liu)(see English language machine translation attached to this or a previous office action).
Regarding claim 1:
Kato discloses:
A device for producing microneedles (figure 6a; ¶0006 and figure 2b), comprising a microneedle female mold (32), a vacuum chamber (33), a filling mechanism (30a) and an evacuation mechanism (33a), a surface (see the top of 33) of the microneedle female mold provided with grooves (see the grooves A in figure 1 below) matching with the microneedles (11), the filling mechanism at least partially disposed in the vacuum chamber (as shown in figure 6(a) 30a is within 33) and configured to release a solution (solution within 30c) for producing the microneedles (as shown in figures 6(b) to figures 9(c)).
Kato fails to disclose:
The evacuation mechanism connected to the vacuum chamber and configured to evacuate the vacuum chamber, the vacuum chamber comprising a feeding cavity, a filling cavity and a discharging cavity, which are independent of one another,
the feeding cavity configured to receive the microneedle female mold in a non-negative pressure state,
the evacuation mechanism configured to evacuate the feeding cavity that has received the microneedle female mold therein,
the filling cavity configured to receive, in a negative pressure state, the microneedle female mold transported from the feeding cavity in the negative pressure state,
the discharging cavity configured to receive, in the negative pressure state, the microneedle female mold transported from the filling cavity in the negative pressure state and to undergo vacuum destruction after the microneedle female mold is received therein.
Liu teaches:
A vacuum production line that can be used to modify processes that include a single station where the workpiece needs to enter a vacuum cavity so that the workpiece can be produced (¶0003). The modification further includes adding a vacuum chamber comprising a feeding cavity (2), a filling cavity (1) and a discharging cavity (3), which are independent of one another (as shown in figure 1). The feeding cavity configured to receive the workpiece (200) in a non-negative pressure state (¶0016 indicates the workpiece is received in a non-negative pressure or non-vacuum state in feeding cavity 2), the evacuation mechanism (pump; ¶0006) configured to evacuate the feeding cavity that has received the workpiece therein (¶0016 further indicates the feeding cavity 2 transitions to a vacuum before being fed to filling chamber 1), the filling cavity (1) configured to receive, in a negative pressure state, the workpiece transported from the feeding cavity in the negative pressure state (received via 6 as shown in figure 1; ¶0016), the discharging cavity (3) configured to receive, in the negative pressure state, the workpiece transported from the filling cavity in the negative pressure state and to undergo vacuum destruction after the microneedle female mold is received therein (¶0017). Further, a vacuum production line includes valve in the feeding cavity and the discharging cavity that are connected to a pump (¶0013).
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 Kato to replace the single vacuum chamber with a vacuum chamber comprising a feeding cavity, a filling cavity and a discharging cavity as taught by Liu in order to increase the production efficiency of the microneedle assembly process (¶0003). Further, this is a simple substitution of one known element (single vacuum chamber as taught by Kato) for another (vacuum chamber including a feeding cavity, a filling cavity and a discharging cavity as taught by Liu) to obtain predictable results (to produce microneedles).
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Figure 1 – figure 6(a) of Kato, annotated by the examiner
Regarding claim 2:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 1 by Kato and Liu:
The device for producing microneedles according to claim 1, further comprising a controller and vacuum breaker valves communicatively connected to the controller, the vacuum breaker valves including a first vacuum breaker valve and a third vacuum breaker valve, the first vacuum breaker valve disposed in the feeding cavity, the third vacuum breaker valve disposed in the discharging cavity (see the first and second control valves connected to the feeding cavity and the discharge cavity as described in ¶0013 of Liu and incorporated into Kato),
the controller configured to control an opening of the first vacuum breaker valve to break vacuum in the feeding cavity and to control an opening of the third vacuum breaker valve to break vacuum in the discharging cavity (see the control valves described in ¶0013 of Liu).
Regarding claim 3:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 1 by Kato and Liu:
The device for producing microneedles according to claim 2, wherein the controller is further communicatively connected to the evacuation mechanism, and wherein the controller is configured to control the evacuation mechanism to evacuate the discharging cavity, the filling cavity and the feeding cavity (see the controller as part of the control valves connected to the filling cavity and feeding cavity and the pump as described in ¶0013 of Liu).
Regarding claim 5:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 1 by Kato and Liu:
The device for producing microneedles according to claim 1, further comprising a leveling mechanism (see the conveyor 8 of the at the location C as shown in figure 2 below of Liu incorporated into the Kato as part of the filling cavity 1), wherein the filling cavity defines therein a casting location (see the casting location B in figure 2 below) and a leveling location (see the leveling location C in figure 2 below);
when the filling cavity is in the negative pressure state and when the microneedle female mold is located at the casting location in the filling cavity, the filling mechanism is configured to cast the solution onto the surface of the microneedle female mold (see the negative pressure state of the filling cavity 1 of Liu incorporated into Kato and microneedle mold and casting location of Kato);
after the solution is cast onto the microneedle female mold in the filling cavity, the microneedle female mold is configured to be transported to the leveling location (conveyor 8 of Liu moves the workpiece to location C which further levels the microneedle mold as shown in figure 1 of Liu), and the leveling mechanism is configured to perform a leveling process on the microneedle female mold with the solution cast thereon, so that the solution uniformly spreads over the surface of the microneedle female mold (by the conveyor 8 holding the mold so that it is leveled so the microneedles can be formed before they are passed into the discharge chamber 3 which has been incorporated into Kato accordingly, further, the tray is horizontally translated).
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Figure 2 – figure 1 of Liu, annotated by the examiner
Regarding claim 12:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 1 by Kato and Liu:
The device for producing microneedles according to claim 1, further comprising a tray (see the tray D in figure 2 above for supporting the workpiece of Liu incorporated into Kato) for carrying the microneedle female mold (see the mold 22 of Kato) therein, wherein the tray is able to carry microneedle female mold of different sizes (inherent since a tray is capable of carrying various this).
Regarding claim 20:
Kato discloses:
A method for producing microneedles (figure 6a; ¶0006 and figure 2b), comprising:
providing a microneedle female mold (32), a surface of the microneedle female mold (see the top of 33) provided with grooves (see the grooves A in figure 1 above) matching with the microneedles (11);
casting a solution (solution within 30c) for producing the microneedles (11), in the negative pressure state (as shown in figure 6(a) 30a is within 33), onto the surface of the microneedle female mold (32) by a filling mechanism (30a)and;
performing a demolding process (figures 9a-9c), thereby obtaining the microneedles (11/31) after the microneedle female mold with the solution thereon solidifies and is molded.
Kato fails to disclose:
placing the microneedle female mold into a feeding cavity in a non-negative pressure state and then drawing a vacuum in the feeding cavity by an evacuation mechanism so that the feeding cavity and the microneedle female mold are both in a negative pressure state;
transporting the microneedle female mold in the negative pressure state from the feeding cavity in the negative pressure state into a filling cavity in the negative pressure state,
performing a leveling process on the microneedle female mold with the solution cast thereon by a leveling mechanism so that the solution is uniformly flattened on the surface of the microneedle female mold,
transporting the microneedle female mold with the solution casted thereon from the filling cavity in the negative pressure state into a discharging cavity in the negative pressure state and maintaining the filling cavity in the negative pressure state;
after the microneedle female mold with the solution casted thereon is transported into the discharging cavity in the negative pressure state, destroying a vacuum in the discharging cavity in the negative pressure state so that the discharging cavity is in the non-negative pressure state, and obtaining the microneedle female mold with the solution thereon.
Liu teaches:
A vacuum production line that can be used to modify processes that include a single station where the workpiece needs to enter a vacuum cavity so that the workpiece can be produced (¶0003). The modification further includes adding a vacuum chamber comprising a feeding cavity (2), a filling cavity (1) and a discharging cavity (3), which are independent of one another (as shown in figure 1). The feeding cavity configured to receive the workpiece (200) in a non-negative pressure state (¶0016 indicates the workpiece is received in a non-negative pressure or non-vacuum state in feeding cavity 2), the evacuation mechanism (pump; ¶0006) configured to evacuate the feeding cavity that has received the workpiece therein (¶0016 further indicates the feeding cavity 2 transitions to a vacuum before being fed to filling chamber 1), the filling cavity (1) configured to receive, in a negative pressure state, the workpiece transported from the feeding cavity in the negative pressure state (received via 6 as shown in figure 1; ¶0016), the discharging cavity (3) configured to receive, in the negative pressure state, the workpiece transported from the filling cavity in the negative pressure state and to undergo vacuum destruction after the microneedle female mold is received therein (¶0017). Further, a vacuum production line includes valve in the feeding cavity and the discharging cavity that are connected to a pump (¶0013). The feeding cavity (2), filling cavity (1) and discharging cavity (3) include a conveyor (8) for transferring the workpiece through each cavity and further the filling cavity includes a leveling and casting location (C and B respectively in figure 2 above).
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 Kato to replace the single vacuum chamber with a vacuum chamber comprising a feeding cavity, a filling cavity and a discharging cavity as taught by Liu in order to increase the production efficiency of the microneedle assembly process (¶0003). Further, this is a simple substitution of one known element (single vacuum chamber as taught by Kato) for another (vacuum chamber including a feeding cavity, a filling cavity and a discharging cavity as taught by Liu) to obtain predictable results (to produce microneedles). This would add the step of placing the mold into a feeding cavity, transporting the mold into filing cavity with a molding location and leveling process, transporting the mold to a discharge cavity were the vacuum is destroyed.
Regarding claim 21:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 20 by Kato and Liu:
The method for producing microneedles according to claim 20, further comprising:
after the microneedle female mold in the negative pressure state is transported from the feeding cavity in the negative pressure state into the filling cavity in the negative pressure state, destroying a vacuum in the feeding cavity in the negative pressure state so that the feeding cavity is in the non-negative pressure state and gets ready for reception of the next microneedle female mold therein (as indicated in ¶0017 of Liu and incorporated into Kato); and/or
the method for producing microneedles further comprising:
after the vacuum in the discharging cavity in the negative pressure state is destroyed, transporting the microneedle female mold with the solution thereon out of the discharging cavity in the non-negative pressure state, thereby emptying the discharging cavity in the non-negative pressure state (as indicated in ¶0017 of Liu and incorporated into Kato); and
after the discharging cavity in the non-negative pressure state is emptied, drawing a vacuum in the discharging cavity by the evacuation mechanism so that the discharging cavity is in the negative pressure state and ready for reception of the next microneedle female mold that has been undergone a leveling process (as indicated in ¶0017 of Liu and incorporated into Kato).
Regarding claim 23:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 20 by Kato and Liu:
The method for producing microneedles according to claim 20, further comprising:
at a casting location in the filling cavity, casting the solution onto the surface of the microneedle female mold in the negative pressure state by the filling mechanism (see the casting location B in figure 2 above); and
at a leveling location in the filling cavity, performing the leveling process on the microneedle female mold with the solution cast thereon by the leveling mechanism (see the conveyor 8 of the at the location C as shown in figure 2 below of Liu incorporated into the Kato as part of the filling cavity 1);
wherein at the leveling location, the microneedle female mold is carried in a tray (D in figure 2 above), wherein the leveling mechanism drives the tray to move and thereby effectuates the leveling process on the microneedle female mold, the movement of the tray comprising at least one of horizontal rotation, horizontal translation, shaking and vertical swinging (by the conveyor 8 holding the mold so that it is leveled so the microneedles can be formed before they are passed into the discharge chamber 3 which has been incorporated into Kato accordingly, further, the tray is horizontally translated).
Regarding claim 32:
Kato discloses:
A method for producing microneedles (figure 6a; ¶0006 and figure 2b), comprising:
providing a microneedle female mold (32) and a vacuum chamber (33), a surface of the microneedle female mold (see the top of 33) provided with grooves (see the grooves A in figure 1 above) matching with the microneedles (11),
after the microneedle female mold (32) with the solution thereon solidifies and is molded, performing a demolding process (figures 9a-9c).
Kato fails to disclose:
the vacuum chamber comprising a filling cavity and a discharging cavity, which are independent of each other;
placing the microneedle female mold into the filling cavity in a non-negative pressure state and casting a solution for producing the microneedles onto the surface of the microneedle female mold by a filling mechanism;
performing a leveling process on the microneedle female mold by a leveling mechanism so that the solution is uniformly flattened on the surface of the microneedle female mold;
drawing a vacuum in the filling cavity by an evacuation mechanism so that the filling cavity and the microneedle female mold are both in a negative pressure state;
transporting the microneedle female mold having undergone the leveling process into the discharging cavity in the negative pressure state, destroying a vacuum in the discharging cavity in the negative pressure state so that the discharging cavity is in the non-negative pressure state, and obtaining the microneedle female mold with the solution thereon; and
Liu teaches:
A vacuum production line that can be used to modify processes that include a single station where the workpiece needs to enter a vacuum cavity so that the workpiece can be produced (¶0003). The modification further includes adding a vacuum chamber comprising a feeding cavity (2), a filling cavity (1) and a discharging cavity (3), which are independent of one another (as shown in figure 1). The feeding cavity configured to receive the workpiece (200) in a non-negative pressure state (¶0016 indicates the workpiece is received in a non-negative pressure or non-vacuum state in feeding cavity 2), the evacuation mechanism (pump; ¶0006) configured to evacuate the feeding cavity that has received the workpiece therein (¶0016 further indicates the feeding cavity 2 transitions to a vacuum before being fed to filling chamber 1), the filling cavity (1) configured to receive, in a negative pressure state, the workpiece transported from the feeding cavity in the negative pressure state (received via 6 as shown in figure 1; ¶0016), the discharging cavity (3) configured to receive, in the negative pressure state, the workpiece transported from the filling cavity in the negative pressure state and to undergo vacuum destruction after the microneedle female mold is received therein (¶0017). Further, a vacuum production line includes valve in the feeding cavity and the discharging cavity that are connected to a pump (¶0013). The feeding cavity (2), filling cavity (1) and discharging cavity (3) include a conveyor (8) for transferring the workpiece through each cavity and further the filling cavity includes a leveling and casting location (C and B respectively in figure 2 above).
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 Kato to replace the single vacuum chamber with a vacuum chamber comprising a feeding cavity, a filling cavity and a discharging cavity as taught by Liu in order to increase the production efficiency of the microneedle assembly process (¶0003). Further, this is a simple substitution of one known element (single vacuum chamber as taught by Kato) for another (vacuum chamber including a feeding cavity, a filling cavity and a discharging cavity as taught by Liu) to obtain predictable results (to produce microneedles). This would add the step of placing the mold into a feeding cavity, transporting the mold into filing cavity with a molding location and leveling process, transporting the mold to a discharge cavity were the vacuum is destroyed.
Regarding claim 33:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 32 by Kato and Liu:
The method for producing microneedles according to claim 32, further comprising:
at a casting location in the filling cavity (see the casting location B in figure 2 above), casting the solution onto the surface of the microneedle female mold by the filling mechanism (casting the solution via 30a as shown in figure 6a of Kato); and
at a leveling location in the filling cavity (see the leveling location C in figure 2 below), performing the leveling process on the microneedle female mold with the solution cast thereon by the leveling mechanism (as the mold horizontally translates along 8 within filling cavity 2 of Liu incorporated into Kato).
Regarding claim 34:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 32 by Kato and Liu:
The method for producing microneedles according to claim 33, wherein the microneedle female mold is passed through the filling cavity and the discharging cavity in a tray (see the tray D in figure 2 above for supporting the workpiece of Liu incorporated into Kato), wherein at the leveling location, the leveling mechanism drives the tray to move and thereby effectuates the leveling process on the microneedle female mold, the movement of the tray comprising at least one of horizontal rotation, horizontal translation, shaking and vertical swinging (by the conveyor 8 holding the mold so that it is leveled so the microneedles can be formed before they are passed into the discharge chamber 3 which has been incorporated into Kato accordingly, further, the tray is horizontally translated).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20160038729 A1 to Kato and CN 203242709 U to Liu et al. (Liu) as applied to claim 3 above, and further in view of US 3829263 A to Yao et al. (Yao).
Regarding claim 4:
Kato and Liu fail to disclose:
The device for producing microneedles according to claim 3, further comprising a sensor assembly communicatively connected to the controller, the sensor assembly comprising a first sensor, a second sensor and a third sensor,
wherein the feeding cavity is provided with the first sensor; the filling cavity is provided with the second sensor; the discharging cavity is provided with the third sensor; and the controller is configured to control, based on pressure information detected by the first sensor, the second sensor and the third sensor, degrees of vacuum in the respective cavities.
Yao teaches:
A vacuum chamber (12; column 3, lines 30-45) for pressure casting synthetic resin (see figure 1 and 2). The vacuum chamber further includes a pressure sensor (50/52) and a pump (40) for maintaining the vacuum pressure in the vacuum (column 4, lines 55-65). Further, a circuit/controller is arranged between the valves and the pressure sensors to control the valves (column 5, lines 20-30).
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 Kato and Liu to further include pressure sensors (first-third) and valves in the feeding, filling and discharging cavity to control the pressure to the chambers with the controller between the sensors and valves as taught by Yao in order to regulate the pressure within the feeding, filling and discharging cavity (column 4, lines 55-65).
Allowable Subject Matter
Claims 6-8, 13-15, 25 and 27 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
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The following is pertinent prior art:
US-20120101457-A1
KATO
Casting the microneedle under vacuum (¶0067)
US-20170239855-A1
NIITSU
Microneedle with conveyor 2a
US-20060157345-A1
Huang
See the conveyor 70/71
US-20160136408-A1
KATO
See the microneedle mold with under vacuum (¶0051)
US-20120018914-A1
Utashiro
See the microneedle mold (11/12)
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached on (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WESLEY G HARRIS/Examiner, Art Unit 3783
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