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 .
Response to Amendment
The Drawings were previously objected to for claimed subject matter not being shown regarding the deformation sensor of claims 2 and 3, terminals of claims 4, 5, and 16-17, thermal insulator of claim 10, and fastening means of claim 13 as previously filed. Each of those claims has been cancelled and thus that objection to the Drawings is thus withdrawn. The drawings remain objected to.
Claims 2, 8, and 9 were previously objected to for various typographical errors and have been amended or cancelled, and the claim objections are thus withdrawn.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “8” has been used to designate both a catheter and an SEA opening. The reference number 7 is used for the catheter in the Specification however the reference number shown in the Drawings which appears to be drawn to the catheter is number 8.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claim(s) 1, 6, 9, 11, and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Seward et al. (US 20020142119, henceforth Seward) in view of Griffin et al. (US 20040193140, henceforth Griffin) and Northrop (US 20210275779, henceforth Northrop).
Regarding claim 1, Seward discloses a guiding assembly for catheters (catheter with articulated tip as in [0089]), comprising at least two coupling means (anchors 123 at the end of SMA ribbons 122, see fig. 16; while this is not explicitly shown for the catheter arrangement of fig. 18, it is understood to be present since figs. 14 and 16 are also drawn to a section of a catheter as disclosed in [0097]-[0100]); at least one shape memory alloy (SMA) actuator (called out first SMA strip 87, fig. 18B) electrically activated by providing heating (see [0019], [0067]-[0069], and [0071], optical heating with lasers is disclosed as the main embodiment with resistive heating disclosed as another acceptable and well known method of activating an SMA) resulting from an electric current (current from fiber optics is used with light to create heat, see [0019], [0067]-[0069], and [0071]) wherein the at least one SMA actuator is fixed to the at least two coupling means (see fig. 16, the SMA ribbon 122 in that embodiment is connected to the supporting anchors 123 as shown); and at least one part of the at least one SMA actuator (the longitudinal extension in the middle of the ribbon as shown in figs. 14 and 16) is positioned between the at least two coupling means (see fig. 16, all ribbons 122 are shown being longitudinally between the anchors 123); and at least one shape element (called out second SMA strip 87, fig. 18B) fixed to the at least two coupling means or the at least one SMA actuator (see fig. 16, all ribbons 122 are shown being longitudinally between the anchors 123; since this was true for the first SMA and the SEA of Seward is the same as the SMA of Seward, the same understanding applies here), wherein at least one part of the at least one shape element (the longitudinal extension in the middle of the ribbon 122 as shown in figs. 14 and 16) is positioned between the at least two coupling means (see fig. 16, all ribbons 122 are shown being longitudinally between the anchors 123); wherein the at least one SMA actuator has an initial shape (straightened shape which the strips are forced into below the set temperature, see [0102]) below a transition start temperature Ts (see fig. 1, there is a start temperature and a finish temperature for the chosen material), a final shape (curved shape which the strips are annealed into and which they return to under proper heating conditions, [0102]) at or above a transition finish temperature TF (see fig. 1, there is a start temperature and a finish temperature for the chosen material), and transitional shapes between the initial start shape and the final shape (see fig. 1, the chosen materials go through a continuum of stiffnesses, which determine the shape of the SMA, as the temperature of the material changes) according to the temperature between the transition start temperature Ts and the transition finish temperature TF of the at least one SMA actuator (see fig. 1, the material properties are what determine where along the curves the shape can be found, see also [0053] and [0102]).
Seward does not explicitly disclose that the provision of heat to activate the SMA is by resistive heating where electrical current is provided for the resistive heating. Northrop teaches activation of shape memory alloy actuators with resistive heating where electrical current is passed through the SMAs to provide resistive heat ([0082]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used resistive heating resulting from an electric current to have heated the SMA and activate the SMA actuator as claimed as Seward teaches resistive heating to be a known, art acceptable way of heating an SMA ([0071]) and because Northrop teaches that this resistive heating can be achieved by using current as claimed ([0082]).
Seward as modified does not disclose that the shape element is a super-elastic alloy which is configured to provide a recovery force to reposition the SMA from the final shape to the initial shape when the current is cut. Griffin teaches that shape memory elements can have compositions which make them into superelastic alloys (see [0045]-[0047]), and that superelastic alloys are designed to recover their shapes without significant deformation upon the application and release of stress ([0047], “Such alloys can be desirable in some embodiments because a suitable superelastic alloy will provide a reinforcing member 26 that is exhibits some enhanced ability, relative to some other non-superelastic materials, of substantially recovering its shape without significant plastic deformation, upon the application and release of stress, for example, during placement of the catheter in the body”; [0051], “Thereafter, the reinforcing member 26 may recover its preformed, austenitic shape when released from the stress of navigation, at a temperature that may be substantially above the final austenite transition temperature without significant plastic, or otherwise permanent deformation”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the shape element of Seward to be a superelastic alloy as Griffin teaches superelastic alloys to be beneficial for recovering their initial shapes after bending and tortuous navigation without significant deformation (Griffin [0047] and [0051]). The composition ratios of the SEA of Griffin have the same ratios as those disclosed by Applicant (see Applicant’s specification at [0028]) and thus will have the same material properties and recovery force.
Regarding claim 6, Seward as modified by Northrop and Griffin (henceforth Seward as modified) discloses the assembly of claim 1 wherein the initial shape is in a straight form (straightened shape which the strips are forced into below the set temperature, see [0102] and see the rejection of claim 1 above) and the final shape is in a bent form (curved shape which the strips are annealed into and which they return to under proper heating conditions, [0102] and see the rejection of claim 1 above), or wherein the initial shape is in a bent form and the final shape is in a straight form (this is an optional claim requirement which is an alternative to the called out limitations).
Regarding claim 9, Seward as modified discloses the assembly of claim 1 wherein the at least one SMA actuator and the at least one SEA member are extending longitudinal between the at least two coupling means (see fig. 16, the SMA ribbons 122 showing the arrangement of SMA strips 87 in the chosen embodiment of fig. 18 both extend longitudinally between the anchors 123 as shown).
Regarding claim 11, Seward as modified discloses the assembly of claim 1 further comprising a catheter tube opening (the hollowed out interior of catheter lumen 84, fig. 18a) for receiving a catheter (the hollow interior of lumen 84 is capable of receiving a catheter where it is a hollowed out opening which extends cylindrically and could have another, smaller catheter passed through it).
Regarding claim 14, Seward as modified discloses the assembly of claim 1 further comprising an external cover or coating surrounding the at least one SMA actuator and the at least one SEA member (the wall of catheter lumen 84 as shown in fig. 18c is an external covering which covers the SMA actuator and the SEA member as shown).
Claim(s) 7, 8, and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Seward et al. (US 20020142119, henceforth Seward) in view of Griffin et al. (US 20040193140, henceforth Griffin) and Northrop (US 20210275779, henceforth Northrop) as applied to claim 1 above, and further in view of Ducharme et al. (US 20150065953, henceforth Ducharme).
Regarding claim 7, Seward as modified discloses the assembly of claim 1.
Seward as modified does not disclose the assembly further comprising a resilient member for assisting positioning the at least one SMA actuator into the initial shape from the transitional shapes or the final shape when the electric current is cut. Ducharme teaches an assembly (catheter 10, fig. 1) having an SMA actuator (EMP actuator 12, fig. 11) which changes shapes ([0041]) further comprising a resilient member (stiff helical strip 40, fig. 11) for assisting positioning the at least one SMA actuator into the initial shape from the transitional shapes or the final shape when the electric current is cut (see [0059], the member is stiff in its shape such that it assists with a returning to an unbiased shape from a biased shape).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the resilient member of Ducharme to the assembly of Seward to provide kink resistance and to provide torque as needed to the assembly as it is inserted into a patient (see Ducharme [0059]).
Regarding claim 8, Seward as modified discloses the assembly of claim 7 wherein the resilient member is in the form of a helical spring (see fig. 11, strip 40 is a helical spring).
Regarding claim 12, Seward as modified by Northrop and Ducharme discloses the assembly of claim 7 wherein the at least two coupling means comprises recesses for mounting each of the at least one SMA actuator, each of the at least one SEA member, or the resilient member (the spaces where the SMA and SEA are mounted into the anchor 123 as shown in fig. 16 are considered to be recesses as the anchors must provide a space where the SMA members are mounted, and that space is considered to be a recess for mounting as claimed).
Response to Arguments
Applicant’s arguments, see pgs. 8-10 of Applicant’s Remarks, filed 12/03/2025, with respect to the rejection(s) of claim(s) 1 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Seward, Northrop, and Griffin.
Regarding Applicant’s arguments towards Northrop and that one of ordinary skill in the art would not have been able to change heating modalities between Seward and Northrop, it is the Examiner’s position that one of ordinary skill in the art would have been able to substitute the heating method of Seward with the heating method of Northrop as each reference teaches its heating method as an acceptable way to heat an SMA to yield the desired shape changes, especially where Seward discloses that resistive heating is known in the art as an alternative to light heating ([0071]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL J MARRISON whose telephone number is (703)756-1927. The examiner can normally be reached M-F 7:00a-3:30p ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SAMUEL J MARRISON/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783