DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on April 7, 2026 has been entered.
Currently, claims 1-20 are pending with claims 19 and 20 withdrawn, and claims 1, 4-11, 13 and 14 amended. The following is a complete response to the April 7, 2026 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 .
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 14-16 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 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 elongated shaft 16 and heating assembly 48; the Examiner notes that the heating assembly with respect to figure 5 is disclosed in [0065] as “a shape-set helix” as shown in figure 6 with [0060] setting forth that the heating assembly include a heating element 43 with a wire 44 wrapped around a shape-set core 46; Paragraph [0062] then contemplates that a shape memory nitinol core member 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) 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), and a temperature sensor (see figure 12 with the temperature sensor TC within the coil 58).
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 at least paragraph [0062] providing for the shape memory material in the form of the Nitinol core member; [0062] further discusses that the heating element remains in an unexpanded shape until heated thereby transitioning to an expanded shape), and wherein delivering energy to the shape memory material member causes the shape memory material member to self-expand 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 1-6, 8-9 and 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over Turovskiy et al. (US Pat. Pub. 2014/0276718 A1) further in view of Stevens et al. (US Pat. Pub. 2008/0292255 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”).
Turovskiy fails to specifically contemplate, however, that the shape memory material heating element is specifically a shape memory wire that provides for the various structural and functional limitations required by claim 1. Stevens discloses an exemplary alternative manner of expanding/deploying a shape memory wire being made from a shape memory material and having an unexpanded shape and an expanded shape. Stevens further provides that the raising of the temperature of the shape memory wire functions to transition the shape memory wire from the unexpanded shape to the expanded shape.
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 replaced the Nichrome wire and expandable member arrangement contemplated by Turovskiy with the shape memory wire as in Stevens to provide for a known alternative manner of deploying such wire capable of applying heat within the body. Stevens readily contemplates the swapping between other manners of deployment including the use of a similar deployment sheath arrangement as in Turovskiy, where either arrangement is appreciated as functioning equally as well as one another to provide the requisite expansion of the shape memory wire within the body upon the heating of the wire.
Regarding claim 2, Turovskiy, in view of the combination with Stevens in the rejection of claim 1 above, provides the first conductor is configured to deliver energy from a battery to the shape memory wire (see [0040]. [0051], [0081]).
Regarding claim 3, Turovskiy, in view of the combination with Stevens in the rejection of claim 1 above, discloses a handle with a battery, wherein the elongate element is configured to be coupled to the handle (See [0051]).
Regarding claim 4, Turovskiy, in view of the combination with Stevens in the rejection of claim 1 above, provides that the energy comprises direct current to resistively heat the shape memory wire (see [0098] providing for DC current).
Regarding claim 5, Turovskiy, in view of the combination with Stevens in the rejection of claim 1 above, provides that the elongate element further comprises a temperature sensor disposed proximate the shape memory wire (see figure 12 with the temperature sensor TC within the coil 58).
Regarding claim 6, Turovskiy, in view of the combination with Stevens in the rejection of claim 1 above, provides for a controller to control energy delivered to the shape memory wire based on temperatures sensed by the temperature sensor (see at least [0051] providing for a controller with [0035]).
Regarding claim 8, Turovskiy, in view of the combination with Stevens in the rejection of claim 1 above, provides that the shape memory wire comprises a material that is more electrically resistive than that of the first conductor. The Examiner notes that the combined shape memory wire is found to be resistive to heat when in comparison to the various conductors connected thereto. Such a position is taken in view of the disclosure in Turovskiy at paragraph [0055] providing that heating element 43 is made to be resistive to heat, as well as in view of the teaching in [0199] of Stevens providing for similar direction for the shape memory wire being formed of Nitinol and in [0177] of the energy device to be a heater wire or coil.
Regarding claim 9, Turovskiy, in view of the combination with Stevens in the rejection of claim 1 above, provides that the shape memory wire 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 wire and retracted to uncover the shape memory material heating element (sheath as in [0068]).
Regarding claim 12, in view of the combination in the rejection of claim 12 above, the combination with Stevens provides that that the shape memory material comprises a conductive shape memory material (via Stevens [0199] providing for Nitinol).
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 wire to resistively heat the shape memory material heating element (see [0098]).
Claim 17 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 16 above, and further in view of Esch et al. (US Pat. Pub. 2015/0272654 A1).
Regarding claim 17, while Turovskiy contemplates controlling energy delivered to the expandable shape memory material member, 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.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Turovskiy et al. (US Pat. Pub. 2014/0276718 A1) in view of Stevens et al. (US Pat. Pub. 2008/0292255 A1) as applied to claim 6 above, and further in view of Esch et al. (US Pat. Pub. 2015/0272654 A1).
Regarding claim 7, while Turovskiy contemplates controlling energy delivered to the shape memory material heating element (per claim 7), 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) in view of Stevens et al. (US Pat. Pub. 2008/0292255 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 5-7 of the Remarks filed April 7, 2026, with respect to the rejection of claim 1 under 35 U.S.C. 102(a)(1) as being anticipated by Turovskiy have been fully considered and are persuasive.
Specifically, Applicant has highlighted the amendments to independent claim 1 to specifically require a shape memory wire and not the prior recited shape memory material heating element on page 5 of the Remarks, and has further provided remarks with respect to the structural configuration of the heating assembly in the prior-cited arrangement in Turovskiy in at least paragraph [0069]. The Examiner, upon review of Applicant’s remarks and the various portions of the disclosure of Turovskiy (paragraphs [0062], [0064] and [0069], has found persuasive Applicant’s argument that the prior heating element of Turovskiy is not specifically, itself, a shape memory wire as required by claim that a) has energy delivered thereto by a first conductor, b) is made from a shape memory material with an unexpanded shape and an expanded shape and c) functions to transition from the unexpanded shape to the expanded shape via the raising of the temperature of the shape memory wire. Said differently, Turovskiy contemplates a Nichrome heating wire wrapped about a Nitinol core member where the core member, and not the heating wire, functions to provide for the expansion of the entirety of the heating element.
Accordingly, it is for at least the reasoning set forth above that the rejection of independent claim 1 and its respective dependent claims under 35 U.S.C. 102 as anticipated by Turovskiy has been withdrawn. However, upon further consideration, the follow new grounds of rejection have been set forth in the action above to address claim 1 and its respective dependent claims:
Claims 1-6, 8-9 and 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over Turovskiy et al. (US Pat. Pub. 2014/0276718 A1) further in view of Stevens et al. (US Pat. Pub. 2008/0292255 A1).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Turovskiy et al. (US Pat. Pub. 2014/0276718 A1) in view of Stevens et al. (US Pat. Pub. 2008/0292255 A1) as applied to claim 6 above, and further in view of Esch et al. (US Pat. Pub. 2015/0272654 A1).
Claims 10 is rejected under 35 U.S.C. 103 as being unpatentable over Turovskiy et al. (US Pat. Pub. 2014/0276718 A1) in view of Stevens et al. (US Pat. Pub. 2008/0292255 A1) as applied to claim 1 above, and further in view of Matsui et al. (US Pat. Pub. 2018/0344380 A1).
It is the Examiner’s position that the newly proffered rejection under 35 U.S.C. 103 readily addresses the noted deficiency in Turovskiy in view of the alternative arrangement of an expandable, shape-memory heating wire per the disclosure of Stevens for at least the reasoning set forth in the Action above.
Applicant's arguments on page 7 of the Remarks filed April 7, 2026 with respect to rejection of independent claim 14 under 35 U.S.C. 102 as anticipated by Turovskiy have been fully considered but they are not persuasive.
Applicant contends on page 7 that the amended requirement in claim 14 of “wherein delivering energy to the shape memory material member causes the expandable shape memory material member to self-expand from the unexpanded shape to the expanded shape and contact the wall of the blood vessel” defines the claim over the Turovskiy reference for substantially similar reasoning as set forth on pages 5-7 of the Remarks with respect to claim 1. The Examiner fails to find these arguments as persuasive with respect to the limitations set forth in claim 14.
The Examiner agrees with Applicant’s statement on page 7 of the remarks that “Claims 1 and 14 may differ in scope”. In particular, claim 14 requires “an expandable shape memory material member” that is made from a shape memory material whereas claim 1 presently requires “a shape memory wire” made from a shape memory material. The Examiner is of the position that the expandable shape memory material member recitation of claim 14 allows for a much different interpretation than the argued for shape memory wire set forth in claim 1. The Examiner is further of the position that a “member” as set forth in claim 14 can readily be interpreted as more than a single structure thereby providing for the claimed expandable shape memory material member to be equated to the heating assembly 48 in Turovskiy with the combined structure of the heating element 43 having the wire 44 and shape-set core member 46.
Turovskiy then further provides that this expandable shape memory material member is made from a shape memory material that has an unexpanded shape and an expanded shape in view of the disclosure in at least paragraph [0062] providing for the shape memory material in the form of the Nitinol core member. Paragraph [0062] further discusses that the heating element remains in an unexpanded shape until heated thereby transitioning to an expanded shape. Last, the disclosure of Turovskiy discloses that the delivering energy to the shape memory material member causes the shape memory material member to self-expand from the unexpanded shape to the expanded shape and contact the wall of the blood vessel. This is, again, set forth in the disclosure of paragraph [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 Examiner notes that much of the arguments with respect to claim 1 are focused on the requirement in Turovskiy of its heating assembly to include a heating wire and a shape-memory, expandable core member rather than the claimed shape memory wire. This requirement is simply not reflected in the current language of claim 14 and the Examiner fails to find any language or interpretation that precludes the shape memory material heating element from being interpreted to include multiple structural portions such as the heating wire 44 and shape-memory core member 46 in Turovskiy.
As such, it is for at least the reasoning set forth above that the Examiner finds that Applicant’s arguments with respect to the rejection of claim 14 under 35 U.S.C. 102 as anticipated by Turovskiy are unpersuasive and the rejection remains tenable.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Danek et al (US Pat. Pub. 2015/0305794 A1) provides for shape-memory expandable heating members for treating a location within a patient’s body as in paragraph [0125].
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached at (571) 272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Ronald Hupczey, Jr./Primary Examiner, Art Unit 3794
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