DETAILED ACTION
Applicant’s amendments and remarks, filed October 27, 2025, are fully acknowledged by the Examiner. Currently, claims 1-20 are pending with claims 19 and 20 withdrawn and claims 1-18 amended. The following is a complete response to the October 27, 2025 communication.
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 .
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.
Claim Rejections - 35 USC § 102
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 1-6, 8-9, 11-16 and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Turovskiy et al. (US Pat. Pub. 2014/0276718 A1).
Regarding claim 1, Turovskiy provides for an endovenous device capable of treating a blood vessel, comprising an elongate element (element 48) comprising a first conductor (see figure 12 with a first one of the wires for connecting 26 to an end of 58), a second conductor (see figure 12 with a second one of the wires for connecting 26 to an end of 58), and a shape memory material heating element (coil 58; see [0069] providing for the use of a shape-set helix and with [0062] contemplating that the shape memory material in the form of Nitinol functions such that “the heating element does not open up to its expanded configuration until after it is positioned at the treatment sire and current is applied to heat the heating elements”), the first conductor configured to deliver energy to the shape memory material heating element to raise a temperature of the heating element to damage a wall of the blood vessel (see [0098]), and the second conductor configured to conduct energy away from the shape memory material heating element (see [0098]).
Turovskiy further provides that the shape memory material heating element is made from a shape memory material and has an unexpanded shape and an expanded shape (see each of paragraphs [0062] and [0069] as cited above), and wherein raising the temperature of the shape memory material heating element causes the shape memory material heating element to transition from the unexpanded shape to the expanded shape and contact the wall of the blood vessel (again, [0062] contemplating that the shape memory material in the form of Nitinol functions such that “the heating element does not open up to its expanded configuration until after it is positioned at the treatment sire and current is applied to heat the heating elements”).
Regarding claim 2, Turovskiy provides the first conductor is configured to deliver energy from a battery to the shape memory material heating element (see [0040]. [0051], [0081]).
Regarding claim 3, Turovskiy discloses a handle with a battery, wherein the elongate element is configured to be coupled to the handle (See [0051]).
Regarding claim 4, Turovskiy provides that the energy comprises direct current to resistively heat the shape memory material heating element (see [0098] providing for DC current).
Regarding claim 5, Turovskiy provides that the elongate element further comprises a temperature sensor disposed proximate the shape memory material heating element (see figure 12 with the temperature sensor TC within the coil 58).
Regarding claim 6, Turovskiy provides for a controller to control energy delivered to the shape memory material heating element based on temperatures sensed by the temperature sensor (see at least [0051] providing for a controller with [0035]).
Regarding claim 8, Turovskiy provides that the shape memory material heating element comprises a material that is more electrically resistive than that of the first conductor (see [0055] providing that heating element 43 is made to be resistive to heat when in comparison to the various conductors connected thereto.).
Regarding claim 9, Turovskiy provides that the shape memory material heating element comprises a geometry that is more electrically resistive than that of the first conductor (See [0061] discussing the control of the pitch of the heating element in comparison to the shape of the first conductor).
Regarding claim 11, Turovskiy provides for an outer tube configured to be advanced to cover the shape memory material heating element and retracted to uncover the shape memory material heating element (sheath as in [0068]).
Regarding claim 12, Turovskiy provides that the shape memory material heating element comprises a conductive shape memory material (as per the disclosure in each of [0062] and [0069]).
Regarding claim 13, Turovskiy provides that the first conductor is configured to deliver at least one of direct current (DC) or alternative current (AC) to the shape memory material heating element to resistively heat the shape memory material heating element (see [0098]).
Regarding claim 14, Turovskiy provides for an endovenous device for treating a blood vessel comprising an elongate element comprising an expandable shape memory material member (see figure 5 with 16 and 48; see [0069] providing for the use of a shape-set helix and with [0062] contemplating that the shape memory material in the form of Nitinol functions such that “the heating element does not open up to its expanded configuration until after it is positioned at the treatment sire and current is applied to heat the heating elements”), a conductor (34), and a temperature sensor (see figure 12 with the temperature sensor TC within the coil 58), the expandable member configured to expand to contact a wall of the blood vessel (see at least [0069] providing for 48 to expand), and the conductor configured to deliver energy to the expandable member to damage the wall of the blood vessel (via the delivery of energy via 34 to element 32 to generate heat).
Turovskiy further provides that the expandable shape memory material member is made from a shape memory material and has an unexpanded shape and an expanded shape (see each of paragraphs [0062] and [0069] as cited above), and wherein delivering energy to the shape memory material member causes the shape memory material member to transition from the unexpanded shape to the expanded shape and contact the wall of the blood vessel (again, [0062] contemplating that the shape memory material in the form of Nitinol functions such that “the heating element does not open up to its expanded configuration until after it is positioned at the treatment sire and current is applied to heat the heating elements”).
Regarding claim 15, Turovskiy provides that the energy comprises DC current that resistively heats the expandable shape memory material member to damage the wall of the blood vessel with thermal energy (see [0030], [0031], [0051], [0062] and [0098]).
Regarding claim 16, Turovskiy provides for a controller to control energy delivered to the expandable shape memory material member based on temperatures sensed by the temperature sensor (see [0035]).
Regarding claim 18, Turovskiy provides that the expandable shape memory material member is configured to self-expand from the unexpanded shape to the expanded shape can contact the wall of the blood vessel (see [0062], [0064] and [0095]).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 7 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Turovskiy et al. (US Pat. Pub. 2014/0276718 A1) as applied to claims 6 and 16 respectively above, and further in view of Esch et al. (US Pat. Pub. 2015/0272654 A1).
Regarding claims 7 and 17, while Turovskiy contemplates controlling energy delivered to the shape memory material heating element (per claim 7) or the expandable shape memory material member (per claim 17), Turovskiy fails to specifically contemplate that the controller utilizes pulse-width modulation to control energy delivered to the element/member. Esch discloses a similar device as that of Turovskiy and specifically contemplates the use of pulse-width modulation to control energy supplied to a resistive heating element (see [0090], [0091] and [0156]). Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have utilized a pulse-width modulation control for controlling the energy delivering to the heating element of Turovskiy in order to, for example, provide control over the temperature of the heating element. Esch readily displays that such modulation is well known in the art and suitable for such control including when heating within internal lumens within the body.
Claims 10 is rejected under 35 U.S.C. 103 as being unpatentable over Turovskiy et al. (US Pat. Pub. 2014/0276718 A1) as applied to claim 1 above, and further in view of Matsui et al. (US Pat. Pub. 2018/0344380 A1).
Regarding claim 10, while Turovskiy provides for the selection of the resistance of the shape memory material heating element (see [0081]) but fails to provide that the heating element comprises a conductor having a cross-sectional size that is small than that of the first conductor.
Matsui provides for a particular manner of providing for a resistive heating element that has a great resistance than the conductors connected to the heating element. Specifically, Matsui provide for the use of a small cross-sectional area for the pattern 932 than the conductors 941 such that “thermal resistance of the wiring patterns 932 per unit length in the longitudinal direction is higher than thermal resistance of conductors 941 (see [0051]). Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have utilized a heating element with a differing geometry in the form of a smaller cross-section area than that of the connected conductors to result in the higher resistance required for heating element to function to resistively generate heat along its length. Matsui provides that such is a well-known manner of construction of such a heating element to result in the already-contemplated higher resistance in Turovskiy.
Response to Arguments
Applicant’s arguments, see pages 5-6 of the Remarks filed October 27, 2025 with respect to the prior rejection of claims 1, 2, 4-6, 8 and 11 under 35 U.S.C. 102(a)(1) as anticipated by Paamand have been fully considered and are persuasive. Specifically, Paamand fails to provide for the claimed heating element in the form of a shape memory material heating element such that “the shape memory material heating element is made from a shape memory material and has an unexpanded shape and an expanded shape, and wherein raising the temperature of the shape memory material heating element causes the shape memory material heating element to transition from the unexpanded shape to the expanded shape and contact the wall of the blood vessel”. Accordingly, the rejection of claims 1, 2, 4-6, 8 and 11 under 35 U.S.C. 102(a)(1) as anticipated by Paamand has been withdrawn.
Applicant's arguments on pages 6-7 of the Remarks filed October 27, 2025 with respect to the rejection of each of independent claims 1 and 14 under 35 U.S.C. 102(a)(1) as anticipated by Turovskiy have been fully considered but they are not persuasive.
Applicant specifically alleges on pages 6-7 that while “Turovskiy may describe a self-expanding deployment mechanism, nowhere does Turovskiy describe a heating element as a shape memory material heating element that is made from a shape memory material”. Applicant has cited to paragraphs [0064] and [0095] of Turovskiy to support this position. This is not persuasive.
The Examiner has updated each of the rejections of independent claims 1 and 14 in the action above to address the amendments set forth in each claim. The Examiner respectfully disagrees with Applicant’s characterization of Turovskiy in the Remarks, and specifically points to the disclosure in at least [0062] of Turovskiy of the heating element to be formed from a shape memory material in the form of Nitinol functions such that “the heating element does not open up to its expanded configuration until after it is positioned at the treatment sire and current is applied to heat the heating elements”.
Thus, the Examiner cannot find Applicant’s arguments as persuasive for at least the reasoning set forth in the rejections and remarks above.
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 RONALD HUPCZEY, JR whose telephone number is (571)270-5534. The examiner can normally be reached Monday - Friday; 8 am - 4 pm.
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/Ronald Hupczey, Jr./Primary Examiner, Art Unit 3794