DETAILED ACTION
This office action is in response to applicant’s election filed October 20, 2025.
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 .
Response to Election/Restriction
Applicant’s election without traverse of the Invention I (Claims 1-10), in response to the election/restriction requirement mailed August 27, 2025, is acknowledged.
Claims 11-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions. Election was made without traverse in Paper filed October 20, 2025. A complete reply to the final rejection must include cancellation of nonelected claims or other appropriate action (37 CFR 1.144) See MPEP § 821.01.
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.
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 1-2 are rejected under 35 U.S.C. 103 as being unpatentable over Smith et al. (Smith) (Patent/Publication Number US 2023/0190471 A1) in view of Kitahara et al. (Kitahara) (Patent/Publication Number US 2010/0021322).
Regarding claim 1, Smith discloses an implantable fluid-operated inflatable device (100, 200, 400) (e.g. See Paragraphs [0019, 0048, 0069]), comprising: a fluid control system (108, 114) configured to control fluid flow between a fluid reservoir (102, 202, 302, 450) and an inflatable member (104) (e.g. See Paragraphs [0021, 0049]), the fluid control system including: a base plate (210) (e.g. See Paragraphs [0053] The electronic pump assembly 206 may include a hermetic fluid chamber 210 disposed inside of the hermetic enclosure 208. ….. The hermetic fluid chamber 210 may include one or more metal-based materials. In some examples, the hermetic fluid chamber 210 is a Titanium container. …. The hermetic fluid chamber 210 may be fluidly connected to the fluid reservoir 202 and the inflatable member 204. …..) (e.g. See Paragraphs [0048, 0053-0054]); a deformable diaphragm [having a first surface, wherein the first surface includes a textured surface] (e.g. See Paragraphs [0035, 0039, 0057]); a fluid chamber (110, 210, 410) [defined between the base plate and the deformable diaphragm], the fluid chamber being in fluidic connection with the fluid reservoir and with the inflatable member (e.g. See Paragraphs [0047] In some examples, the electronic pump assembly 106 includes a hermetic fluid chamber 110 disposed inside of the hermetic enclosure 108. The hermetic fluid chamber 110 may be a separate air-tight (or substantially air-tight) container that is within the hermetic enclosure 108. The hermetic fluid chamber 110 may include one or more metal-based materials. In some examples, the hermetic fluid chamber 110 is a Titanium container. The hermetic fluid chamber 110 may isolate the fluid from the electronics (e.g., the controller 114, the battery 116, etc.). In other words, the electronics section may be isolated (e.g., completely isolated) from the fluid via the hermetic fluid chamber 110. The hermetic fluid chamber 110 may be fluidly connected to the fluid reservoir 102 and the inflatable member 104. .......) (e.g. See Paragraphs [0021, 0047, 0053-0054]); and a piezoelectric element (120, 220-1, 220-2) [having a second surface, the first surface of the deformable diaphragm and the second surface of the piezoelectric element being adhesively attached, the piezoelectric element being operable to repeatedly change a volume of the fluid chamber by deforming the deformable diaphragm to pump fluid from the fluid reservoir to the inflatable member] (e.g. See Paragraphs [0035] In some examples, the pump 120 is a piezoelectric pump. In some examples, a piezoelectric pump may be a diaphragm micropump that uses actuation of a diaphragm to drive a fluid. In some examples, a piezoelectric pump may include one or more piezo pumps (e.g., piezo elements), which may be implemented by a substrate layer (e.g., a single substrate layer) of high-voltage piezo elements or may be implemented by multiple substrate layers (e.g., stacked substrate layers) of low-voltage piezo elements. .......) (e.g. See Paragraphs [0035-0036, 0057]).
However, Smith fails to disclose that a deformable diaphragm having a first surface, wherein the first surface includes a textured surface, and a piezoelectric element having a second surface, the first surface of the deformable diaphragm and the second surface of the piezoelectric element being adhesively attached, the piezoelectric element being operable to repeatedly change a volume of the fluid chamber by deforming the deformable diaphragm to pump fluid from the fluid reservoir to the inflatable member.
Kitahara teaches that it is conventional in the art, to use a fluid control system (10) including: a deformable diaphragm (2, 23, 33a) having a first surface (See Figures 1-3), wherein the first surface includes a textured surface (See Figures 1-3) (e.g. See Paragraphs [0020-0021, 0023]), and a piezoelectric element (21, 22) having a second surface, the first surface of the deformable diaphragm (23, 33a) and the second surface of the piezoelectric element being adhesively attached (e.g. See Paragraphs [0023] The diaphragm driving portion 2a comprises a piezoelectric element (PZT) 21 which deforms due to voltage, an electrode layer 22 which transmits the control voltages to the piezoelectric element 21, a diaphragm sheet 23 which is deformed by the piezoelectric element 21, a tubular shaped housing 24 to which the diaphragm sheet 23 is fixed on an outer periphery by adhesion or welding, and an insulator film 25 which isolates the diaphragm unit 2 electrically from the pump chamber unit 1. The insulator film 25 has elasticity and driven following to the diaphragm sheet 23. .......) (e.g. See Paragraphs [0023, 0025]), the piezoelectric element being operable to repeatedly change a volume of the fluid chamber by deforming the deformable diaphragm to pump fluid from the fluid reservoir to the inflatable member (e.g. See Paragraphs [0023, 0025, 0029-0031]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made, to use the deformable diaphragm having a first surface, wherein the first surface includes a textured surface, and a piezoelectric element having a second surface, the first surface of the deformable diaphragm and the second surface of the piezoelectric element being adhesively attached, the piezoelectric element being operable to repeatedly change a volume of the fluid chamber by deforming the deformable diaphragm to pump fluid from the fluid reservoir to the inflatable member of Smith, as taught by Kitahara for the purpose of controlling amount of liquid delivery to the patient more precisely, so as to protect the fluid transferring system from failure, and further improve the performance and the efficiency of the pumping system, since the use thereof would have been routinely practiced by those with ordinary skill in the art to maintain high efficiency of a fluid pressure delivery system.
Regarding claim 2, Smith discloses wherein the deformable diaphragm (33b) includes metal (e.g. See Paragraphs [0040] According to the diaphragm pump 10 of this embodiment, since the driven membrane 33c is multilayered by forming as a lamination film of the resin film 33d and the electric conductive film 33e appressed each other, the mechanical strength of the driven membrane 33c is reinforced, and thus, the electric conductive material can be made much thinner, …. Moreover, the driven membrane 33c of the lamination film can be utilized the ready-made double-layered film of a resin film and a metal foil appressed each other, so that cost reduction can be realized.) (e.g. See Paragraphs [0013, 0039-0040]).
Claims 3-10 are rejected under 35 U.S.C. 103 as being unpatentable over Smith et al. (Smith) (Patent/Publication Number US 2023/0190471 A1) in view of Kitahara et al. (Kitahara) (Patent/Publication Number US 2010/0021322), and further in view of Saaski et al. (Saaski) (Patent/Publication Number US 5,585,011).
Regarding claim 3, both Smith and Kitahara disclose all the claimed limitation as discussed above except that the deformable diaphragm includes titanium.
Saaski teaches that it is conventional in the art, to use the deformable diaphragm (36, 84, 134, 214) includes titanium (See Column 55, lines 21-31: Suitable materials for the substrate 132 and the membrane 134 may be metals (such as titanium), glasses, ceramics, plastics, polymers (such as polyimides), elements (such as silicon), various chemical compounds (such as sapphire, and mica), and various composite materials. In general, because the dimensions of the pump 130's various components may not be as critical as the dimensions of the various components of the regulator 32 of FIGS. 1-2, there may be more options regarding the materials from which the pump 130's substrate 132 and membrane 136 may be made.) (e.g. See Column 55, lines 10-31).
It would have been obvious to one having ordinary skill in the art at the time the invention was made, to use the deformable diaphragm includes titanium of Smith and Kitahara, as taught by Saaski for the purpose of controlling amount of liquid delivery to the patient more precisely, so as to prevent the membrane from failure, and further improve the performance and the efficiency of the pumping system, since the use thereof would have been routinely practiced by those with ordinary skill in the art to maintain high efficiency of a fluid pressure delivery system.
Regarding claim 4, Saaski further discloses wherein the textured surface includes an erratic texture pattern (as such, the different materials for making the membranes having different patterns) (e.g. See Column 25, lines 20-32: Suitable materials for the substrate 34 and the membrane 36 may be metals (such as titanium), glasses, ceramics, plastics, polymers (such as polyimides), elements (such as silicon), various chemical compounds (such as sapphire, and mica), and various composite materials. The substrate 34 and the membrane 36 may be assembled together in any suitable leak-proof way. Alternatively, the substrate 34 and the membrane 36 may be bonded together in any suitable leak-proof way, such as by anodically bonding them together; such as by fusing them together (as by the use of heat or ultrasonic welding); and such as by using any suitable bonding materials, such as adhesive, glue, epoxy, solvents, glass solder, and metal solder.) (e.g. See Column 25, lines 7-37; Col. 56, lines 10-40).
Regarding claim 5, Saaski further discloses wherein the erratic texture pattern includes a bead-blasted pattern (as such, the different materials for making the membranes having different patterns) (e.g. See Column 25, lines 7-37; Col. 56, lines 10-40).
Regarding claim 6, Saaski further discloses wherein the textured surface includes a periodic texture pattern (as such, the different materials for making the membranes having different patterns) (e.g. See Column 25, lines 7-37; Col. 56, lines 10-40).
Regarding claim 7, Saaski further discloses wherein the periodic texture pattern includes a multidimensional texture pattern (as such, the different materials for making the membranes having different patterns) (e.g. See Column 25, lines 7-37; Col. 56, lines 10-40).
Regarding claim 8, Saaski further discloses wherein the multidimensional texture pattern includes a laser-etched pattern (as such, the different materials for making the membranes having different patterns) (e.g. See Column 25, lines 7-37; Col. 56, lines 10-40).
Regarding claim 9, Saaski further discloses an epoxy layer between the first surface and the second surface, wherein the epoxy layer adhesively attaches the first surface and the second surface (e.g. See Column 25, lines 20-32: Suitable materials for the substrate 34 and the membrane 36 may be metals (such as titanium), glasses, ceramics, plastics, polymers (such as polyimides), elements (such as silicon), various chemical compounds (such as sapphire, and mica), and various composite materials. The substrate 34 and the membrane 36 may be assembled together in any suitable leak-proof way. Alternatively, the substrate 34 and the membrane 36 may be bonded together in any suitable leak-proof way, such as by anodically bonding them together; such as by fusing them together (as by the use of heat or ultrasonic welding); and such as by using any suitable bonding materials, such as adhesive, glue, epoxy, solvents, glass solder, and metal solder.) (e.g. See Column 25, lines 7-37; Col. 56, lines 10-40).
Regarding claim 10, Saaski further discloses wherein the textured surface includes features of less than 100 microns (e.g. See Column 47, lines 45-51: By way of example, the diaphragm pump 130 may have a weight of about 0.6 grams; and may have the following physical parameters. The substrate 132 may be a square having sides about 1.30 cm long, and a thickness of about 0.5 mm. The membrane 136 may have a thickness of about 25 microns. .....) (e.g. See Column 47, lines 45-65).
Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure and consists of seven patents:
Kudo et al. (Pat./Pub. No. US 2023/0340951), Hansen et al. (Pat./Pub. No. US 2004/0115068), Susi et al. (Pat./Pub. No. US 2019/0192017), East et al. (Pat./Pub. No. US 7198250), Van Lintel et al. (Pat./Pub. No. US 5759015), Richter et al. (Pat./Pub. No. US 11131299), and Kondo et al. (Pat./Pub. No. US 2023/0286273), all discloses a fluid pump for use with fluid dispensing system.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Primary Examiner Binh Tran whose telephone number is (571) 272-4865. The examiner can normally be reached on Monday-Friday from 8:00 a.m. to 4:00 p.m.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisors, Mark Laurenzi, can be reach on (571) 270-7878. The fax phone numbers for the organization where this application or proceeding is assigned are (571) 273-8300 for regular communications and for After Final communications.
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Binh Q. Tran
/BINH Q TRAN/
Primary Examiner, Art Unit 3748
January 10, 2026