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 .
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Applicant is advised that should claim 5 be found allowable, claim 8 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim 11 is objected to because of the following informalities: in lines 1-2, “wherein the controller is configured to controller is configured to” should apparently read --wherein the controller is configured to--. 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 16-20 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.
Claim 16 recites the limitation “fluid” in line 2 (two instances). It is not clear if this is intended to refer to the same fluid recited in claim 10 or to separate fluid.
Claim 17 is rejected by virtue of its dependence upon claim 16.
Claim 18 recites the limitations “an active valve” in lines 3-4 and “an implantable device” in line 4. It is not clear if this is intended to refer to the same active valve and implantable device recited in line 1 of the claim or to separate components.
Claims 19 and 20 are rejected by virtue of their dependence upon claim 18.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 2, 4, 6, 7, and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kanayama et al. (JPH 07158757 A; cited in the IDS filed 03 August 2025; hereinafter known as “Kanayama”).
Regarding claim 1, Kanayama discloses an active valve capable of being used in an implantable device (Abstract; [0001]; Fig. 6), the active valve comprising: a base plate 10 defining an opening 11; a piezo element 30; a diaphragm actuator 20 coupled to the piezo element; and a protrusion 22 coupled to the diaphragm actuator, the diaphragm actuator, in response to the piezo element being activated, is configured to move the protrusion into the opening in a first direction until the protrusion contacts a portion of the base plate (Fig. 6; [0007]-[0009]; [0011]; [0024]).
Regarding claim 2, Kanayama discloses that the protrusion includes a tapered conical portion (Fig. 6; [0024]).
Regarding claim 4, Kanayama discloses that the opening includes a tapered conical hole (Fig. 6; [0024]).
Regarding claim 6, Kanayama discloses that the diaphragm actuator is coupled to the base plate ([0008]).
Regarding claim 7, Kanayama discloses that the diaphragm actuator includes a first surface and a second surface, 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. 6).
Regarding claim 9, Kanayama 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 ([0018]; [0020]).
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 3, 5, and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Kanayama as applied to claim 1 above, and further in view of Herz et al. (U.S. Pub. No. 2013/0055889 A1; hereinafter known as “Herz”). Kanayama discloses the invention as claimed, see rejection supra, but fails to expressly disclose that the protrusion or the diaphragm actuator includes a metal-based material. Herz discloses a similar device (Abstract; Fig. 7I) comprising a protrusion 746 and diaphragm actuator 110 that comprise a metal-based material in order to be less costly in production and to provide higher flexibility ([0106]; [0132]; [0165]). 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 Kanayama with a metal-based material, as taught by Herz, in order to be less costly in production and to provide higher flexibility.
Claims 10, 11, 18, and 19 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 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, 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. Kanayama discloses an active piezoelectric valve (Abstract; [0001]; Fig. 6), the active valve comprising: a base plate 10 defining an opening 11; a piezo element 30; a diaphragm actuator 20 coupled to the piezo element; and a protrusion 22 coupled to the diaphragm actuator, wherein the piezo element is controllably activated to move the protrusion into the opening in a first direction until the protrusion contacts a portion of the base plate, in order to smoothly control the discharge of fluid (Fig. 6; [0007]-[0009]; [0011]; [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 Weber with an active valve as taught by Kanayama in order to smoothly control the discharge of fluid.
Regarding claim 11, the combination of Weber and Kanayama discloses the invention as claimed, see rejection supra, and Kanayama 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 ([0018]; [0020]).
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 an active valve of an 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. Kanayama discloses a method for actuating an active piezoelectric valve (Abstract; [0001]; Fig. 6) comprising applying a voltage to a piezo element 30 of the active valve, the active valve including a base plate 10 defining an opening 11, a diaphragm actuator 20 coupled to the piezo element; and a protrusion 22 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, in order to smoothly control the discharge of fluid (Fig. 6; [0007]-[0009]; [0011]; [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 Weber with such an active valve and actuating it in such a manner, as taught by Kanayama, in order to smoothly control the discharge of fluid.
Regarding claim 19, the combination of Weber and Kanayama discloses the invention as claimed, see rejection supra, and Kanayama further 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 ([0018]; [0020]).
Claims 12-14, 16, 17, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Weber and Kanayama as applied to claims 10 and 18 above, and further in view of Herz.
Regarding claim 12, the combination of Weber and Kanayama discloses the invention as claimed, see rejection supra, and Kanayama further discloses that the protrusion includes a needle portion, the needle portion including a tapered conical portion (Fig. 6; [0024]). The combination of Weber and Kanayama fails to expressly disclose that the needle portion is a metallic needle portion. Herz discloses a similar device (Abstract; Fig. 7I) comprising a protrusion 746 that comprises a metallic material in order to be less costly in production and to provide higher flexibility ([0106]; [0132]; [0165]). 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 Kanayama with a metallic material, as taught by Herz, in order to be less costly in production and to provide higher flexibility.
Regarding claim 13, the combination of Weber, Kanayama, and Herz discloses the invention as claimed, see rejection supra, Kanayama further discloses that the opening on the base plate including a tapered conical hole configured to receive the tapered conical portion (Fig. 6; [0024]), and Herz further discloses that the base plate includes a metal-based material ([0084]; [0129]; [0132]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the combination of Weber, Kanayama, and Herz with a metal-based material for the base plate, as taught by Herz, in order to be less costly in production and to provide higher flexibility.
Regarding claim 14, the combination of Weber and Kanayama discloses the invention as claimed, see rejection supra, but fails to expressly disclose that the diaphragm actuator is welded to the base plate. Herz discloses a similar device (Abstract; Fig. 7I) comprising a diaphragm actuator 110 that is welded to a base plate 750 in order to connect the components with no gaps ([0042]; [0098]; [0103]; [0123]; ultrasonic bonding). 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 Kanayama by welding the diaphragm actuator to the base plate, as taught by Herz, in order to connect the components with no gaps.
Regarding claim 16, the combination of Weber and Kanayama discloses the invention as claimed, see rejection supra, but fails to disclose that the opening is an inlet port configured to receive fluid, the base plate defining an outlet port to output fluid. Herz discloses a similar device (Abstract; Fig. 7I) comprising a base plate 750 comprising an opening that is an inlet port 752 configured to receive fluid, the base plate defining an outlet port 754 to output fluid, in order to pump fluid with less sticking and resistance ([0041]; [0170]-[0171]). 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 Kanayama with such a configuration of inlet and outlet ports, as taught by Herz, in order to pump fluid with less sticking and resistance.
Regarding claim 17, the combination of Weber, Kanayama, and Herz 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 20, the combination of Weber and Kanayama discloses the invention as claimed, see rejection supra, and Kanayama further discloses forming a seal with the protrusion and the base plate (Fig. 6; [0024]). The combination of Weber and Kanayama fails to expressly disclose that seal is a metal-to-metal seal. Herz discloses a similar device (Abstract; Fig. 7I) comprising a protrusion 746 and a base plate 750 that each comprise a metal material, wherein the protrusion and base plate form a seal, in order to be less costly in production and to provide higher flexibility ([0084]; [0106]; [0129]; [0132]; [0165]; [0170]-[0171]). 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 Kanayama with so that the seal is a metal-to-metal seal, as taught by Herz, in order to be less costly in production and to provide higher flexibility.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Weber 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 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 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Takeuchi et al. (U.S. Pub. No. 2003/0012666 A1) teaches a similar pump that displaces a conical protrusion to close and open a hole of matching shape. Kitahara et al. (U.S. Pub. No. 2010/0021322 A1) discloses a similar piezo/diaphragm pump wherein the diaphragm is welded to an outer periphery.
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