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 .
This Office Action is responsive to the Amendment filed 05 June 2026. Claims 1-7, 9-15, and 17-22 are currently under consideration. The Office acknowledges the amendments to claims 1, 10, 11, and 18, as well as the cancellation of claims 8 and 16, and the addition of new claims 21 and 22.
Claim Objections
Claims 1, 10, and 18 are objected to because of the following informalities: in each claim, “a shape that differs than” should apparently read --a shape that differs from-- or --a shape that is different than--. Appropriate correction is required.
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.
Claims 1-7 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Herz et al. (U.S. Pub. No. 2013/0055889 A1; hereinafter known as “Herz”), in view of Kanayama et al. (JPH 07158757 A; hereinafter known as “Kanayama”).
Regarding claim 1, Herz discloses an active valve capable of being used in an implantable device (Abstract; Fig. 7I), the active valve comprising: a base plate 750 defining an opening 752, a piezo element 210, a diaphragm actuator 110 coupled to the piezo element, and a protrusion 746 coupled to the diaphragm actuator, the diaphragm actuator, in response to the piezo element being activated, is configured to move the protrusion towards the opening in a first direction until the protrusion contacts a portion of the base plate, wherein the opening is an inlet port configured to receive a fluid, the base plate defining an outlet port 754 to outlet the fluid, the outlet port having a shape that differs than a shape of the inlet port (Fig. 7I; [0168]-[0173]). Herz fails to expressly disclose that the protrusion is moved into the opening. Kanayama discloses a similar active valve (Abstract; Fig. 6) comprising a base plate 10 defining an opening 11, a piezo element 30, a diaphragm actuator 20, and a protrusion 22 coupled to the diaphragm actuator, wherein the diaphragm actuator, in response to the piezo element being activated, is configured to move the protrusion into the opening in order to properly secure the flow path and allow for smooth control of fluid discharge (Fig. 6; [0024]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Herz with such protrusion and opening shapes so that the protrusion is moved into the opening, as taught by Kanayama, in order to properly secure the flow path and allow for smooth control of fluid discharge.
Regarding claim 2, the combination of Herz and Kanayama discloses the invention as claimed, see rejection supra, and Kanayama further discloses that the protrusion includes a tapered conical portion (Fig. 6; [0024]).
Regarding claim 3, the combination of Herz and Kanayama discloses the invention as claimed, see rejection supra, and Herz further discloses that the protrusion includes a metal-based material ([0040]; [0077]; [0084]; [0106]; [0129]; [0132]).
Regarding claim 4, the combination of Herz and Kanayama discloses the invention as claimed, see rejection supra, and Kanayama further discloses that the opening includes a tapered conical hole (Fig. 6; [0024]).
Regarding claim 5, the combination of Herz and Kanayama discloses the invention as claimed, see rejection supra, and Herz further discloses that the diaphragm actuator includes a metal-based material ([0040]; [0077]; [0084]; [0106]; [0129]; [0132]).
Regarding claim 6, the combination of Herz and Kanayama discloses the invention as claimed, see rejection supra, and Herz further discloses that the diaphragm actuator is coupled to the base plate (Fig. 7I).
Regarding claim 7, the combination of Herz and Kanayama discloses the invention as claimed, see rejection supra, and Herz further discloses that the diaphragm actuator includes a first surface 112 and a second surface 114, the piezo element being coupled to the first surface of the diaphragm actuator, the protrusion being coupled to the second surface of the diaphragm actuator (Fig. 7I).
Regarding claim 9, the combination of Herz and Kanayama discloses the invention as claimed, see rejection supra, and Herz further discloses that at least a portion of the protrusion is disposed outside of the opening of the base plate in response to the piezo element not being actuated (Fig. 7I; [0170]-[071]).
Claims 10-14 and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Weber et al. (U.S. Pub. No. 2019/0350712 A1; hereinafter known as “Weber”), in view of Herz and Kanayama.
Regarding claim 10, Weber discloses an implantable device (Abstract; Fig. 1) comprising: a fluid reservoir 102 configured to hold fluid; an inflatable member 104; and an electronic pump assembly 106 including a controller 112 and an active valve ([0027]; [0033]; [0043]-[0044]). Weber also discloses that the electronic pump assembly may be piezoelectric ([0035]). Weber fails to disclose that the active valve includes a base plate defining an opening, the opening is an inlet port configured to receive a fluid, the base plate defining an outlet port to output the fluid, the outlet port having a shape that differs than a shape of the inlet port, a piezo element, a diaphragm actuator coupled to the piezo element, and a protrusion coupled to the diaphragm actuator, wherein the controller is configured to activate the piezo element to move the protrusion into the opening in a first direction until the protrusion contacts a portion of the base plate. Herz discloses an active piezoelectric valve (Abstract; Fig. 7I) comprising: a base plate 750 defining an opening 752, the opening is an inlet port configured to receive a fluid, the base plate defining an outlet port 754 to outlet the fluid, the outlet port having a shape that differs than a shape of the inlet port, a piezo element 210, a diaphragm actuator 110 coupled to the piezo element, and a protrusion 746 coupled to the diaphragm actuator, the piezo element being activatable to move the protrusion towards the opening in a first direction until the protrusion contacts a portion of the base plate, in order to provide improved sealing characteristics and ease of manufacturing (Fig. 7I; [0168]-[0173]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Weber with an active valve as taught by Herz in order to provide improved sealing characteristics and ease of manufacturing.
The combination of Weber and Herz fails to expressly disclose that the protrusion is moved into the opening. Kanayama discloses a similar active valve (Abstract; Fig. 6) comprising a base plate 10 defining an opening 11, a piezo element 30, a diaphragm actuator 20, and a protrusion 22 coupled to the diaphragm actuator, wherein the diaphragm actuator, in response to the piezo element being activated, is configured to move the protrusion into the opening in order to properly secure the flow path and allow for smooth control of fluid discharge (Fig. 6; [0024]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Weber and Herz with such protrusion and opening shapes so that the protrusion is moved into the opening, as taught by Kanayama, in order to properly secure the flow path and allow for smooth control of fluid discharge.
Regarding claim 11, the combination of Weber, Herz, and Kanayama discloses the invention as claimed, see rejection supra, and Herz further discloses that the controller is configured to deactivate the piezo element to move at least a portion of the protrusion out of the opening ([0170]-[0171]).
Regarding claim 12, the combination of Weber, Herz, and Kanayama discloses the invention as claimed, see rejection supra, and further discloses that the protrusion includes a metallic needle portion, the metallic needle portion including a tapered conical portion (Herz: [0040], [0077], [0084], [0106], [0129], [0132]; metallic protrusion; Kanayama: Fig. 6, [0024]; tapered conical needle portion).
Regarding claim 13, the combination of Weber, Herz, and Kanayama discloses the invention as claimed, see rejection supra, and further discloses that the base plate includes a metal-based material (Herz: [0040], [0077], [0084], [0106], [0129], [0132]) and that the opening on the base plate including a tapered conical hole configured to receive the tapered conical portion (Kanayama: Fig. 6, [0024]).
Regarding claim 14, the combination of Weber, Herz, and Kanayama discloses the invention as claimed, see rejection supra, and Herz further discloses that the diaphragm actuator is welded to the base plate ([0042]; [0098]; [0103]; [0123]; ultrasonic bonding).
Regarding claim 17, the combination of Weber, Herz, and Kanayama discloses the invention as claimed, see rejection supra, and Weber further discloses that the inlet port is coupled to the inflatable member and the outlet port is coupled to the fluid reservoir ([0027]; [0031]; [0033]).
Regarding claim 18, Weber discloses a method for actuating an active valve of an implantable device (Abstract; Fig. 1) comprising: receiving a first control signal for the active valve of the implantable device ([0027]; [0033]; [0043]-[0044]). Weber also discloses that the active valve may be piezoelectric ([0035]). Weber fails to disclose that the first control signal is to apply a voltage to a piezo element of the active valve, the active valve including a base plate defining an opening, a diaphragm actuator coupled to the piezo element, and a protrusion coupled to the diaphragm actuator; and moving, in response to actuation of the piezo element, the protrusion into the opening of the base plate in a first direction until the protrusion contacts a portion of the base plate, the opening is an inlet port configured to receive a fluid, the base plate defining an outlet port to output the fluid, the outlet port having a shape that differs than a shape of the inlet port. Herz discloses method for actuating an active piezoelectric valve (Abstract; Fig. 7I) comprising applying a voltage to a piezo element 210 of the active valve, the active valve including a base plate 750 defining an opening 752, a diaphragm actuator 110 coupled to the piezo element, and a protrusion 746 coupled to the diaphragm actuator, and in response to actuation of the piezo element, moving the protrusion towards the opening in a first direction until the protrusion contacts a portion of the base plate, the opening is an inlet port configured to receive a fluid, the base plate defining an outlet port 754 to outlet the fluid, the outlet port having a shape that differs than a shape of the inlet port, in order to provide improved sealing characteristics and ease of manufacturing (Fig. 7I; [0168]-[0173]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Weber with an active piezoelectric valve actuated by applying a voltage, as taught by Herz, in order to provide improved sealing characteristics and ease of manufacturing.
The combination of Weber and Herz fails to expressly disclose that the protrusion is moved into the opening. Kanayama discloses a similar method for actuating an active valve (Abstract; Fig. 6), the active valve comprising a base plate 10 defining an opening 11, a piezo element 30, a diaphragm actuator 20, and a protrusion 22 coupled to the diaphragm actuator, wherein in response to the piezo element being activated, the protrusion is moved into the opening in order to properly secure the flow path and allow for smooth control of fluid discharge (Fig. 6; [0024]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Weber and Herz with such protrusion and opening shapes so that the protrusion is moved into the opening, as taught by Kanayama, in order to properly secure the flow path and allow for smooth control of fluid discharge.
Regarding claim 19, the combination of Weber, Herz, and Kanayama discloses the invention as claimed, see rejection supra, and Herz further discloses receiving a second control signal to not apply the voltage to the piezo element of the active valve; and moving, in response to the second control signal, the protrusion in a second direction such that at least a portion of the protrusion is disposed outside of the opening of the base plate ([0170]-[0171]).
Regarding claim 20, the combination of Weber, Herz, and Kanayama discloses the invention as claimed, see rejection supra, and Herz further discloses forming a metal-to-metal seal with the protrusion and the base plate ([0040], [0077], [0084], [0106], [0129], [0132]).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Weber, Herz, and Kanayama as applied to claim 10 above, and further in view of Forster et al. (U.S. No. 6,227,809; hereinafter known as “Forster”). The combination of Weber, Herz, and Kanayama discloses the invention as claimed, see rejection supra, but fails to expressly disclose that the piezo element is coupled to the diaphragm actuator with an epoxy-based material. Forster discloses a similar device (Abstract; Fig. 1) comprising a piezo element 44 coupled to a diaphragm actuator 38 with an epoxy-based material in order to bond the components to each other with conductivity (col. 7, lines 7-22). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Weber, Herz, and Kanayama by coupling the piezo element to the diaphragm actuator with an epoxy-based material, as taught by Forster, in order to bond the components to each other with conductivity.
Claims 21 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Weber, Herz, and Kanayama as applied to claims 1 and 10 above, and further in view of Killeen et al. (U.S. Pub. No. 2013/0000759 A1; hereinafter known as “Killeen”). The combination of Weber, Herz, and Kanayama discloses the invention as claimed, see rejection supra, but fails to disclose that the inlet port extends along an axis, the outlet port extends along an axis, the axis of the inlet port being disposed at an angle with respect to the axis of the outlet port. Killeen discloses a similar device (Abstract; Figs. 1-3) comprising a piezo element 110 and a diaphragm 120, with inlet ports 131/231/328 and outlet ports 132/232/329, wherein the inlet port extends along an axis, the outlet port extends along an axis, and these axes are disposed at an angle with respect to one another (Figs. 1-3; [0028]-[0048]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Weber, Herz, and Kanayama so that axes of the ports are disposed at an angle with respect to one another, as taught by Killeen, in order to move the fluid in and/or out in desired directions and/or more efficiently.
Response to Arguments
Applicant’s arguments with respect to the objections to claims 8 and 11, as well as the rejection of claims 16-20 under 35 U.S.C. 112(b), have been fully considered and are persuasive in light of the amendments. The objections and rejections have been withdrawn.
Applicant’s arguments with respect to the rejections under 35 U.S.C. 102 and 103 have been fully considered and are persuasive in light of the amendments. Therefore, the rejections have been withdrawn. However, upon further consideration, new grounds of rejection are made, as detailed supra.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THADDEUS B COX whose telephone number is (571)270-5132. The examiner can normally be reached M-F 9am-6pm.
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/THADDEUS B COX/Primary Examiner, Art Unit 3791
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