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 amended objected to; the objection to the Drawings remains. Examiner notes that Applicant indicated that replacement Drawings were filed; no replacement Drawings appear to have been filed.
Claim 1 has been amended. Claims 1, 6-9, 11-12, and 14 remain pending.
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
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]); wherein the electric current is applied to the at least one SMA actuator to deform the at least one SMA actuator from the initial shape toward the final shape ((current from fiber optics is used with light to create heat, see [0019], [0067]-[0069], and [0071], which is what causes the claimed deformation of the SMA actuator between shapes).
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.
Thus, in the modified assembly, Seward as modified by Northrop and Griffin (henceforth Seward as modified) discloses the assembly wherein the at least one SEA member acts against deformation of the at least one SMA actuator during movement from the initial shape toward the final shape (see at least Seward [0067]-[0069], in the modified device, when current is fed to one of the SMA ribbons 87 of fig. 18B and not another, the other element, which is the SEA member in the modified device, is not heated and thus acts to maintain its shape, and since it is acted on by the heated SMA ribbon to change shapes, it is configured to act against this shape change as claimed) and exerts the recovery force for reverse deformation of the at least one SMA actuator when the electric current is cut (in the modified device, the SEA acts only to retain its original shape, and thus when the heating of the SMA ends, the force exerted by the SEA is the recovery force for reverse deformation as claimed).
Regarding claim 6, 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 filed 06/12/2026 have been fully considered but they are not persuasive.
In response to applicant's arguments against the references individually (pgs. 6-10), one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). None of the individual references are considered to disclose the entirety of the claimed invention; the references as relied upon above renders the claimed subject matter obvious in combination with each other.
Applicant has also argued that there is no motivation to combine the references (pgs. 10-13). Examiner respectfully disagrees and finds this unpersuasive.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, each of the references is properly motivated to be combined as indicated in the body of the rejection above with regards to each of the provided motivation and combination statements. For example, one of ordinary skill in the art would have recognized, when provided the disclosure of Seward (especially at [0071]) and the teachings of Northrop (especially in [0082]), that instead of the optical heating arrangement disclosed in Seward, resistive heating could alternatively be used by one of ordinary skill in the art as it is an art-effective equivalent which would could be substituted as a method of heating and changing shapes of SMAs with a reasonable expectation of success and controllability. Regarding the combination with Griffin, Griffin is relied upon for changing the second elastic element of Seward to be a superelastic alloy which is beneficial for shape recovery; the arrangement of the shape elements is disclosed by Seward as explained above. Examiner notes that Ducharme is not relied upon for disclosing the SEA arrangement as argued by Applicant.
Applicant has additionally argued that the relied upon combination would destroy the functionality of the original art and could not require substantial reconstruction (pgs. 13-17). This is respectfully found unpersuasive. The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). While the changing of heating from optical fiber heating to resistive heating (as in the modification of Seward by Northrop) would require modifications to be made, these are within the skill of one of ordinary skill in the art with a reasonable expectation of success, especially since Seward ([0071]) already mentions resistive heating as a known substitute method of heating in the art, and thus it is the Examiner’s position that one of ordinary skill in the art would have been capable of making the modification without destroying the device of Seward. The combination of Seward and Griffin is not a replacement of structures, but rather a changing of material to be a superelastic alloy for beneficial bending properties, which would not destroy the device of Seward as the second shape element of Seward is similarly a bendable shape element. Regarding the addition of Ducharme, one of ordinary skill in the art would be able to configure the structures of the modified device such that the beneficial kink resistance and torqueability of Ducharme could be added to Seward without destroying the device of Seward.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning (pgs. 17-19), it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
In response to applicant's argument that the inventor identified a problem others did not (pgs. 19-20), the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
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 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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/SAMUEL J MARRISON/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
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