DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
2. Applicant's election of Species A (claims 1-5) in the reply filed on 09/22/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)).
Claim Objections
3. Claims 1-5 are objected to because of the following informalities:
In claim 1, lines 8-10: “wherein the position allows for a space between the shape memory alloy coiled-wire and helical grooves for the shape memory alloy coiled-wire to twist freely” should be changed to -- such that a space between the shape memory alloy coiled-wire and helical grooves for the shape memory alloy coiled-wire to twist freely--. --for clarity--
In claim 3, line 2: “three one loops” should be changed to --three --. --for clarity--
In claim 4, lines 3-4: “a stiffness of the enclosure” should be changed to -- a stiffness of the enclosure fitting--. --for consistency--
In claim 5, line 2: “a fluid-reservoir and wherein the method” should be changed to -- a fluid-reservoir, and wherein the method --. --for clarity--
Claim Rejections - 35 USC § 112
4. 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.
5. Claims 1-5 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.
the position
Claim 1 recites the limitation "the position" in line 8. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, the limitation will be interpreted as “a shape memory alloy coiled-wire positioned over the length and in the helical grooves such that a space between the shape memory alloy coiled-wire and the helical grooves allows for the shape memory alloy coiled-wire to twist freely”.
Applicant is required to clarify or to revise the claimed limitation.
Claim Rejections - 35 USC § 103
6. 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.
7. 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.
8. 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.
9. Claims 1-3 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Nason et al. (hereinafter “Nason”) (Patent No.: US 7,052,251 B2) in view of AONUMA (Japanese Publication JP2004092629 (A), English Translation appended).
Regarding claim 1, Nason discloses a method (see Abstract) for actuating a pump (for actuation a fluid pump, see column 9 lines 1-3) comprising:
(a) having an actuation mechanism (actuation mechanism AM, wherein, as stated in column 4 lines 60-67, an actuation of the pump 100 is provided by an SMA wire 128 and return bias spring 130 placed in opposition and/or as stated in column 9 lines 1-5, where the injection stroke (i.e., fluid driven out of the chamber) is actuated by the bias spring) for the pump (for the micropump, as detailed in column 4 lines 60-67), wherein the actuation mechanism (actuation mechanism AM, as shown immediately below) comprising:
(i) a tubular structure (tubular structure of the element 144 or coupler 144, as shown in annotated Figure 3C) with a first end and a second end (as best seen in annotated Figures 1A, the tubular structure or coupler 144 is certainly having a first or left end FE and second or right end SE), and with an outer surface (an outer surface of the coupler 144, which is cylindrical and includes a special curved cut, shaped to admit the SMA wire 128 from a radial surface of the coupler 144, as detailed in column 6 lines 35-50),
(ii) a shape memory alloy wire (shape memory alloy (SMA) wire 128 that is guided to take large radius turns (relative to the wire diameter) to minimize binding of the SMA wire 128 as it contracts and expands, as discussed in column 4 lines 60-67);
(b) placing a fluid inside the tubular structure (driving a fluid from the pump, as stated in column 3 lines 59-62; the fluid pump 100A includes an intake tube 102 to accept a fluid, as discussed in column 4 lines 29-40); and
(c) activating the shape memory alloy wire (the SMA wire 128 is energized to a temperature at or above the transformation temperature. As a result, the SMA wire 128 contract to recover the “memorized' shape (i.e. a shorter length) and in doing so over comes the bias spring 130 force and draws the piston 120 back to expand the pumping chamber 104 volume, as stated in column 5 lines 50-60).
Particularly, Nason demonstrates a fluid pump that, as stated in Abstract, “is coupled to the shape memory wire and driven by the biased spring and shape memory wire to produce a fluid flow.”
Nason, in column 10 lines 29-35, expressly states that “fluid is driven out of the valved chamber by the bias spring as it deforms the shape memory wire and moves the piston”. Likewise, in column 13 lines 1-5, Nason further notes as how a method of pumping fluid, comprising the steps, “where the fluid is drawn into the valved chamber from a reservoir and is driven out of the valved chamber through a conduit.”
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Especially, in column 5 lines 52-67, Nason discloses as how: FIG. 2B illustrates the “intake stroke” phase of the pumping cycle. Here, the SMA wire 128 is energized to a temperature at or above the transformation temperature. As a result, the SMA wire 128 contract to recover the “memorized” shape (i.e. a shorter length) and in doing so overcomes the bias spring 130 force and draws the piston 120 back to expand the pumping chamber 104 volume. In one embodiment, the chamber 104 volume changes from zero to approximately 1 ml. As the chamber 104 volume increases, negative pressure occurs in the chamber causing the intake valve 106 (e.g., a flap valve) to open as fluid is drawn in from the reservoir.
Further, as best seen in annotated Figure 2B, Nason explicitly exhibits that: where the injection stroke (i.e., fluid driven out of the chamber) is actuated by the bias spring.
Still further, with reference to annotated Figure 2B again, Nason evidently illustrates as how: the SMA wire 128 is energized to a temperature at or above the transformation temperature. As a result, the SMA wire 128 contract to recover the “memorized' shape (i.e. a shorter length) and in doing so over comes the bias spring 130 force and draws the piston 120 back to expand the pumping chamber 104 volume (see column 5 lines 50-60).
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Nason, in column 9 lines 6-31, then goes on to describe: FIG. 8A is a flowchart of an exemplary method for pumping a fluid where the injection stroke is driven by the bias spring. The method begins at block 800 where an SMA element is heated to a recovery temperature equal or greater than a transformation temperature of the SMA element. At block 802, the SMA element overcomes the bias spring to return to a memorized shape and draw fluid into a valved chamber at the recovery temperature. At block 804, the SMA element is cooled to a reset temperature below the transformation temperature. At block 806, the bias spring deforms the SMA element and drives fluid out of the valved chamber below the reset temperature. The method is then repeated to produce a pulsatile fluid flow. Alternately, FIG. 8B is a flowchart of an exemplary method for pumping a fluid where the injection stroke is driven by SMA element. The method begins at block 820 where a bias spring deforms the SMA element and draws fluid into a valved chamber at a reset temperature below the transformation temperature of the SMA element. At block 822, an SMA element is heated to a recovery temperature equal or greater than the transformation temperature. At block 824, the SMA element overcomes the bias spring to return to a memorized shape and drive fluid out of the valved chamber at the recovery temperature. At block 826, the SMA element is then cooled to the reset temperature. The method is then repeated to produce a pulsatile fluid flow.
In this disclosure, Nason undoubtedly describes a methodology of activating the shape memory alloy wire 128 which causes a shortening of the tubular structure over the length in between the first end FE and the second end SE and therewith a compression of the fluid resulting in a release of a fluid from the tubular structure, as otherwise, the system cannot normally operate.
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Similarly, in column 7 lines 35-50, Nason further discloses another embodiment of the invention, wherein: FIG. 6A illustrates a cross-section view of a further embodiment of the invention employing the pump in an ultra-compact infusion device 600. The infusion device 600 enclosure is formed from a “turtle shell’ cover 602 attached to the perimeter of a base plate 604. In operation, the infusion device 600 is placed directly on the skin, held by a pressure sensitive adhesive material 606 on the back of the base plate 604, at the infusion site of the user. An integral infusion set, including a piercing member 608 Such as a needle, penetrates the skin for Subcutaneous medication delivery. Other related art infusion devices separate the infusion set from the infusion pump so that fluid is conveyed from the pump to a remote infusion site through a long conduit. This is done to facilitate control or programming by the user.
Then, in column 8 lines 5-17, Nason expressly states that: The enclosure houses a pump 614 (such as the SMA driven pump embodiments previously described), an electronics module 616 to control the pump 614, a battery 618 to power the pump 614 and a fluid reservoir 620. The fluid reservoir 620 can be constructed as a collapsible bag, formed to occupy the free space Surrounding the pump 614 and battery 618 and capable of holding approximately 3.2 ml of fluid.
Clearly, with respect to alternative embodiment, as seen in annotated Figure 6A, Nason successfully demonstrates as how an enclosure or cover 602 encompassing the fluid pump. As such, one skilled in the art would surely recognize that the Nason’s actuation mechanism being designed such that an enclosure fitting would be necessarily encompassing the tubular structure.
Although Nason discloses most of the limitations of the claim, he does not explicitly disclose specifics regarding the enclosure fitting encompassing the tubular structure and/or the outer surface having helical grooves over a length and the SMA wire being a coiled-wire.
Nonetheless, actuation mechanisms having the claimed structure and containing shape memory alloy coiled wire are well-known in the art, as taught by Aonuma.
Aonuma in the same field of endeavor teaches another shape memory-based actuator that, as stated in SOLUTION, “is displacing an elastic member by energizing the shape memory alloy elastic member and heating the elastic member at martensite transformation temperature or higher, an end part of the elastic body threadedly attached to an outer circumference can be moved to a narrow electrode collar with a coil joint by the coil shaped shape memory alloy elastic member, the coil joint having a helical groove which the end part of the elastic member is threadedly attached on formed on an outer circumference, an annular electrode collar having a tapered inner surface getting narrow in a threadedly attached end part side of the elastic member on the outer circumference of the coil joint, and a nut threadedly attached to the end part of the coil joint”.
Notably, in Paragraph [0005], Aonuma discloses as how: The actuator comprises a coil-shaped elastic member made of a shape memory alloy, a coil joint having a spiral groove formed on its outer periphery into which the end of the elastic member is screwed, an annular electrode collar on the outer periphery of the coil joint having a tapered inner surface narrowing toward the screwed end of the elastic member, and a nut screwed onto the end of the coil joint, so that the end of the elastic material screwed onto the outer periphery can be moved toward the narrowed side of the electrode collar together with the coil joint.
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Further, in Paragraph [0015], Aonuma especially teaches that: The casing is made up of a half outer tube 22 and a half inner tube 23 made of heat-resistant synthetic resin, and the half outer tube 22 and half inner tube 23 are fitted together so as to be expandable and retractable. The heat-resistant synthetic resin is a resin that can withstand a heat temperature of 100° C. or higher and is made of polyethylene, polypropylene, or the like, which has good sliding properties. Furthermore, the shape of the casing is not limited to the shape of the embodiment, as long as it is expandable and contractible, like a bellows tube, and can protect and keep warm the coil shape memory alloy elastic member 21 housed inside.
Surely, with reference to annotated Figure 3, Aonuma explicitly exhibits as how the tube 22/23 encompassing the tubular structure therewith the shape memory alloy coiled-wire.
Clearly, disclosing the arrangement of the half outer tube 22 and half inner tube 23 which are fitted together, Aonuma specifically teaches as how an enclosure fitting encompassing the tubular structure therewith the shape memory alloy coiled-wire.
Hence, one of ordinary skill in the art would appreciate that applying an idea of providing enclosure fitting encompassing the tubular structure to further protect the coil shape memory alloy member housed inside, as taught by Aonuma, to another system would improve reliability.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the teaching of using an enclosure, as taught by Aonuma, to the actuation mechanism of Nason, as part of an obvious combination of known prior art structures, in this case the use of enclosure or cover structure, to achieve predictable results, in this case, to further control the fluid flow through the system. See KSR; MPEP 2141 III.
However, most important aspect in Aonuma is his specific arrangement of the spiral grooves that are being in helical configuration while being provided on outer surface.
Aonuma, in Paragraph [0018], explicitly teaches: The assembly process for actuator B involves screwing both ends 1a, 1b of the shape memory alloy elastic member 21 into spiral grooves 24a, 25a formed on the outer periphery of the through holes 24b, 25b of the coil-stopping conductive fittings 24, 25, and fitting insulating collars 26, 27 into the through holes 24a, 25a from both end sides to the inside of the shape memory alloy elastic member, thereby electrically insulating the mounting joints 32, 33, which will be described later, from the elastic member 21.
Consequently, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the groove of Nason into a spiral groove and to make the SMA wire into a coiled-wire, in light of the teachings of Aonuma, in order to better retain the SMA wire on the tubular structure.
Thus modified, one skilled in the art would have been reasonably appraised that the outer surface would be further including helical grooves over a length in between the first end and the second end of the outer surface and/or a shape memory alloy coiled-wire would be further positioned over the length and in the helical grooves and/or the position would be further allowing for a space between the shape memory alloy coiled-wire and helical grooves for the shape memory alloy coiled-wire to further twist freely since Nason shows SMA wire 128 seating in a groove with a space between the groove and the SMA wire, and/or an enclosure fitting or inner/outer tube of Aonuma would be further encompassing the tubular structure therewith the shape memory alloy coiled-wire and the helical grooves, as instantly claimed.
Regarding claims 2 and 3, Nason and Aonuma substantially disclose the method, as claimed and detailed above.
Further, according to the combination, one of ordinary skill in the art would have been reasonably appraised that the shape memory alloy coiled-wire would have at least one loop or revolution.
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Although Nason in view of Aonuma fails to teach the exact limitation of having a least three one loops or revolutions, it has been held in re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955), that “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation," (see MPEP 2144.05 (II)(A)).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nason in view of Aonuma such that the shape memory alloy coiled-wire would be further having at least three one loops or revolutions because such a modification would have been considered a mere design optimization which fails to patentably distinguish over the prior art.
Regarding claim 5, Nason and Aonuma substantially disclose the method, as claimed and detailed above.
Additionally, in column 8 lines 5-18, Nason especially teaches: The enclosure houses a pump 614 (such as the SMA driven pump embodiments previously described), an electronics module 616 to control the pump 614, a battery 618 to power the pump 614 and a fluid reservoir 620. The fluid reservoir 620 can be constructed as a collapsible bag, formed to occupy the free space Surrounding the pump 614 and battery 618 and capable of holding approximately 3.2 ml of fluid. The reservoir 620 can be sealed to the base plate 604 along a seam around its perimeter. The septum fill port 612 mounted in the base plate 604 directly accesses the reservoir 620. An input tube 630 provides a fluid path from the reservoir 620 to the pump 614.
Then, in column 10 lines 38-41, Nason expressly states that: the valved chamber includes an inlet valve for receiving fluid from a reservoir and an outlet valve for driving the fluid out to a conduit.
Certainly, according to the combination, one skilled in the art would surely recognize that the actuation mechanism would be further comprising a fluid-reservoir and/or the method would be further comprising placing the fluid-filled reservoir inside the tubular structure and/or the shortening would be further causing a compression of the fluid-reservoir and therewith a release of the fluid from the fluid-reservoir, as instantly claimed.
10. Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Nason in view of AONUMA, as evidenced by Takahashi et al. (hereinafter “Takahashi”) (Pub. No.: US 2020/0037852 A1).
Regarding claim 4, Nason and Aonuma substantially disclose the method, as claimed and detailed above.
Additionally, in column 5 lines 52-67, Nason specifically teaches that FIG. 2B illustrates the “intake stroke' phase of the pumping cycle. Here, the SMA wire 128 is energized to a temperature at or above the transformation temperature. As a result, the SMA wire 128 contract to recover the “memorized' shape (i.e. a shorter length) and in doing so over comes the bias spring 130 force and draws the piston 120 back to expand the pumping chamber 104 volume. In one embodiment, the chamber 104 volume changes from Zero to approximately 1 ml. As the chamber 104 volume increases, negative pressure occurs in the chamber causing the intake valve 106 (e.g., a flap valve) to open as fluid is drawn in from the reservoir. When the chamber 104 volume reaches 1 ml, the piston hits the limit stop 124 and the chamber 104 is full. Power to the SMA wire 128 can now be eliminated. As the fluid pressure reaches equilibrium, the intake valve 106 closes.
Aonuma, in Paragraph [0036], especially notes as how: the molded elastic member is shaped to the pitch of the spiral groove of the current-carrying metal fitting, so the groove surface of the coil-fastening current-carrying metal fitting and the side surface of the elastic member are securely joined, improving reliability. Furthermore, since the elastic member is housed inside the half tube and heated by direct current, the elastic member is heated uniformly, resulting in a strong deformation force and a fast deformation speed.
Further, it’s a well-established fact that deactivation or stopping of the activation causes the tubular structure to reverse its shortening and return toward its original length, wherein the reversal is driven by elastic restoring forces arising from the stiffness of the enclosure. Obviously, upon deactivation or stopping of the activation, the stiffness of the enclosure causes the tubular structure to reverse the shortening and expand back toward its original dimensions.
As an evidentiary reference, please see Takahashi (US 20200037852 A1) which particularly demonstrates as how: A variable stiffness device includes a first elongated member including high-bending stiffness portions and a low-bending stiffness portion between adjacent high-bending stiffness portions, a second elongated member arranged along the first elongated member and including shape-memory members and a connecting member between adjacent shape-memory members, a heater to heat a shape-memory member in the low-bending stiffness portion to increase the bending stiffness, and a moving mechanism to move the second elongated member relative to the first elongated member. When the heater heats a first shape-memory member in the low-bending stiffness portion, a second shape-memory member next to the first shape-memory member is arranged in a high-bending stiffness portion.
Clearly, according to the combination, one skilled in the art would surely recognize that the shortening of the tubular structure would be further followed by a reversal of the shortening of the tubular structure when the actuation has stopped and/or the reversal would be further caused by a stiffness of the enclosure or tube of Aonuma, as otherwise, the system cannot normally operate.
Prior Art
11. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure and consists of two patents.
US 2018/0372076 A1 and US 11,441,548 B2 are cited to show different shaped memory-based actuators.
Conclusion
12. Any inquiry concerning this communication or earlier communications from the examiner should be directed to LILYA PEKARSKAYA whose telephone number is (571)272-1158. The examiner can normally be reached on Monday to Friday, 9:00-5:00 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Essama Omgba can be reached on 469-295-9278.
The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/L.P/Examiner, Art Unit 3746
/ESSAMA OMGBA/Supervisory Patent Examiner, Art Unit 3746