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 amendments filed on 02/11/2026 have been entered. Claims 1-14 remain pending in the application. The amendments overcome the objections set forth in the previous office action dated 09/11/2025.
Response to Arguments
Applicant's arguments filed 02/11/2026 have been fully considered but they are not persuasive. Applicant argues that De Falco fails to teach a second material having variable rigidity. Applicant argues that a region of cables and plates forming a variable stiffness mechanical assembly region does not constitute a variable stiffness material, and argues that the material surrounding the wires is what must comprise the variable stiffness properties. It is the examiners position that this claim limitations as been met because the rejection does not rely on the combinations of cables and plates as teaching the second material having variable stiffness. Rather, the rejection sets forth that De Falco teaches this region as comprising “compliant segments” that are compressed by retracting the tendons which then increases the stiffness of the section of the needle. The compliant material, which is described in sections 2.1-2.2, is interpreted as the second material – not the mechanical assembly of tendons and plates as suggested by Applicants arguments. Section 2.2 disclose that the compliant material (Specifically Smooth-Sil 940 Silicone as shown in Table 3) is described as nonlinear and thereby creates a variable stiffness in the needle which is controllable to direct the device through changing tissue densities. See page 2188 which states ”the property of the compliant material is nonlinear… therefore, this nonlinear property induces the variation of the stiffness in the overall system”. Therefore, it is the examiners position that the disclosed silicone material adequately teaches the limitation of the claim.
Applicant argues on page 7 that the proposed modifications to De Falco would alter the fundamental principle of operation by changing the mechanical tensioning actuation to be temperature responsive instead. However, it is the examiners position that the modification does not seek to replace or alter the mechanical tensioning operation of the device of De Falco, but rather alter the discloses compliant material which forms a component of the device. Modifying only the properties of the compliant segments by substituting commonly known elastomeric materials would not affect the overall operation of the device. Examiner notes the claims do not recite or require the application of heat, but rather pertain to the materials themselves, and therefore the modification need not change the principle of operation in order to meet the limitations.
Regarding claim 12, which does positively recite an activation voltage coupled to the wire, it is the examiners position that the proposed modification is not changing the principle of operation but rather is applying a known technique to a known device to yield predictable results. The technique taught by Chautems is directed towards solving the same problem as De Falco i.e. how to control steering of the elongate device. Therefore, substitution of a known mechanism for steering would not change the principle of operation because the operation remains the same of having a steerable needle.
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.
Claim(s) 1 is rejected under 35 U.S.C. 103 as being unpatentable over De Falco (De Falco et al., A variable stiffness mechanism for steerable percutaneous instruments: integration in a needle, 2018, Medical & Biological Engineering & Computing 56:2185–2199 (Year: 2018)) in view of Gordon et al. (US 2020/0077991).
Regarding claim 1, De Falco discloses a steerable needle (Abstract, ‘variable stiffness needle’ FIG 2, made steerable by the tendons, section 2.1), comprising: a wire (One tendon) extending a predetermined length (FIG 2a); a first region (tip, FIG 2A) of a first material (The tip is made of aluminum, section 2.2) surrounding a first portion of the wire (At least the distal tip of the wire as it attached at the distal rigid plate); a second region (Mechanism portion in FIG 2A) of a second material that is different than the first material (The compliant segments of the variable stiffness mechanism are made of silicone, different form the first material, section 2.2) surrounding a second portion of the wire (FIG 2a shows the wire passing through the mechanism section), wherein the second material is characterized by a rigidity that is variable in response to an external stimulus (Sections 2.1-2.2 disclose that the compliant segments are compressed by retracting the tendons which then increases the stiffness of the section of the needle. The compliant material is described as nonlinear and thereby creates a variable stiffness in the needle which is controllable to direct the device through changing tissue densities).
De Falco is silent regarding an elastomer surrounding the first region and the second region.
Gordon teaches in the same field of endeavor of biopsy needles (302, FIGs 4-5A, [0072]), a needle having a first region (309, FIG 5A) having a first stiffness ([0073]), a second region (310) having a second stiffness ([0073-0075]), and an elastomer (318, [0076] discloses the flexible jacket/sleeve can be made of pebax, an elastomer) surrounding the first region and the second region (FIG 5A shows 318 extending along both sections 310 and 309).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the first region and the second region of De Falco to be surrounded by an elastomer, as taught by Gordon, for the purpose of providing a covering across the sections and connection between segments to create an impervious flexible barrier so that a vacuum can be applied through the lumen and/or fluid can travel therethrough during use of the needle ([0076]).
Claim(s) 2-11 are rejected under 35 U.S.C. 103 as being unpatentable over De Falco in view of Gordon et al. (US 2020/0077991), further in view of Shan (US 2020/0216630).
Regarding claim 2, De Falco/Gordon discloses the invention substantially as claimed, as set forth above for claim 1.
De Falco is silent regarding wherein the external stimulus is heat.
However, Shan teaches a material (FIG 1) for use with robotic needles ([0035]) wherein the material has variable mechanical stiffness ([0025-0029]), wherein the rigidity of the material is variable in response to an external stimulus in the form of heat ([0025-0029]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the compliant segments in the variable stiffness mechanism of De Falco to be made of the material taught by Shan, and thereby being variable in response to heat, for the purpose of utilizing a commonly known stimulus for altering the rigidity of a material and allowing for customized selection of materials to achieved a desired affect for a particular application ([0027]).
Regarding claims 3-5, De Falco/Gordon discloses the invention substantially as claimed, as set forth above for claim 1.
De Falco is silent regarding the second material comprises an elastomeric matrix having a plurality of particles that are rigid at a first temperature, and flexible at a second, higher temperature, wherein the plurality of particles are formed from a low melting point alloy selected from the group consisting of Field's Metal and Cerrolow 117.
However, Shan teaches a material (FIG 1) for use with robotic needles ([0035]) wherein the material has variable mechanical stiffness ([0025-0029]), wherein the rigidity of the material is variable in response to an external stimulus (In the form of heat, [0025-0029]), and wherein the material comprises an elastomeric matrix (102) having a plurality of particles (104) that are rigid at a first temperature, and flexible at a second, higher temperature ([0027] discloses the tunable particles comprise a material that is rigid at room temperature, but that becomes soft/flexible when heated), wherein the plurality of particles are formed from a low melting point alloy ([0028]) selected from the group consisting of Field's Metal ([0028] discloses the LMPA can be field’s metal) and Cerrolow 117.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the compliant segments in the variable stiffness mechanism of De Falco to be made of the material taught by Shan, and thereby comprising an elastomeric matrix and a plurality of particles formed of Field’s Metal, for the purpose of utilizing variable stiffness material commonly known in the art and thereby allowing for customized selection of materials to achieved a desired affect for a particular application ([0027]).
Regarding claims 6-7, De Falco/Gordon/Shan discloses the invention substantially as claimed, as set forth above for claim 3. The device as modified by Shan further discloses the plurality of particles are formed by a mixture of nickel coated carbon fibers and low melting point alloy particles or the plurality of particles are formed by a mixture of silver coated carbon fibers and low melting point alloy particles ([0029] discloses the material comprising nickel or silver coated carbon fibers. The fibers exist in material 100 in addition to the LMPA of the particles 104).
Regarding claims 8-11, De Falco/Gordon discloses the invention substantially as claimed, as set forth above for claim 1.
De Falco is silent regarding the second material comprises an elastomeric matrix and a tunable foam matrix, wherein the elastomeric matrix is selected from the group consisting of polydimethylsiloxanes, platinum-catalyzed silicones, polyurethanes, silicone polymers, and combinations thereof, and wherein the tunable foam matrix includes a low melting point alloy selected from the group including Field's Metal and Cerrolow 117.
However, Shan teaches a material (FIG 4) for use with robotic needles ([0035]) wherein the material has variable mechanical stiffness ([0031-0035]), wherein the rigidity of the material is variable in response to an external stimulus (In the form of heat, [0032]), and wherein the material comprises an elastomeric matrix (202) and a tunable foam matrix (204), wherein the elastomeric matrix is selected from the group consisting of polydimethylsiloxanes, platinum-catalyzed silicones, polyurethanes, silicone polymers, and combinations thereof ([0031] discloses 202 formed of PDMS), and wherein the tunable foam matrix includes a low melting point alloy selected from the group including Field's Metal and Cerrolow 117 ([0033-0034]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the compliant segments in the variable stiffness mechanism of De Falco to be made of the material taught by Shan, and thereby comprising an elastomeric matrix and a tunable foam matrix formed of Field’s Metal, for the purpose of utilizing variable stiffness material commonly known in the art and thereby allowing for customized selection of materials to achieved a desired affect for a particular application ([0033-0035]).
Claim(s) 1 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over De Falco in view of Chautems (Chautems et al., Magnetic Continuum Device with Variable Stiffness for Minimally Invasive Surgery, 2020, Advanced Intelligent Systems, 2:1900086 (Year: 2020)), in further view of Gordon et al. (US 2020/0077991).
Regarding claims 1 and 12, De Falco discloses a steerable needle (Abstract, ‘variable stiffness needle’ FIG 2, made steerable by the tendons, section 2.1), comprising: a first region (tip, FIG 2A) of a first material (The tip is made of aluminum, section 2.2); a second region (Mechanism portion in FIG 2A) of a second material that is different than the first material (The compliant segments of the variable stiffness mechanism are made of silicone, different form the first material, section 2.2), wherein the second material is characterized by a rigidity that is variable in response to an external stimulus (Sections 2.1-2.2 disclose that the compliant segments are compressed by retracting the tendons which then increases the stiffness of the section of the needle. The compliant material is described as nonlinear and thereby creates a variable stiffness in the needle which is controllable to direct the device through changing tissue densities).
De Falco is silent regarding a wire extending a predetermined length through the first and second region, and wherein the external stimulus comprises an activation voltage coupled to the wire that is sufficient to induce an increase in temperature in the wire.
However, Chautems teaches in the same field of endeavor a steerable device (FIG 1A and 2A) comprising a wire (Heater, FIG 2A, section 2.1), a first region surrounding a first portion of the wire (Base, FIG 2A), a second region surrounding a second portion of the wire (LMPA, FIG 2A, section 2.1) wherein the second material is characterized by a rigidity that is variable in response to an external stimulus (Section 2.1, the LMPA section reduces in rigidity upon application of a current transferred thereto form the copper wire), wherein the external stimulus comprises an activation voltage coupled to the wire that is sufficient to induce an increase in temperature in the wire (Section 2.1, current/voltage is applied through the heater/copper wire, to increase the temperature of the LMPA. This application of voltage and therefore heat decreases the rigidity of the second material).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the device of De Falco to have the wire and second material taught by Chautems, in order to achieve the predictable result of varying the rigidity of the second material using an activation voltage applied to the wire instead of a force applied to the wire.
De Falco is silent regarding an elastomer surrounding the first region and the second region.
Gordon teaches in the same field of endeavor of biopsy needles (302, FIGs 4-5A, [0072]), a needle having a first region (309, FIG 5A) having a first stiffness ([0073]), a second region (310) having a second stiffness ([0073-0075]), and an elastomer (318, [0076] discloses the flexible jacket/sleeve can be made of pebax, an elastomer) surrounding the first region and the second region (FIG 5A shows 318 extending along both sections 310 and 309).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the first region and the second region of De Falco to be surrounded by an elastomer, as taught by Gordon, for the purpose of providing a covering across the sections and connection between segments to create an impervious flexible barrier so that a vacuum can be applied through the lumen and/or fluid can travel therethrough during use of the needle ([0076]).
Claim(s) 13 is rejected under 35 U.S.C. 103 as being unpatentable over De Falco in view of Gordon et al. (US 2020/0077991), further in view of Dillard et al. (US 2013/0225997).
Regarding claim 13, De Falco/Gordon discloses the invention substantially as claimed, as set forth above for claim 1.
De Flaco is silent regarding the material of the wire, specifically the wire comprising nitinol.
However, Dillard teaches a steerable biopsy needle (600A, abstract, [0104]) controlled by a pull wire (604A, [0103-0105]), wherein the wire comprises nitinol ([0105]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the wire of De Falco to comprise nitinol, as taught by Dillard, for the purpose of selecting a material commonly known in the art for having the desired structural and flexibility properties for functioning as a pull wire to steer an elongate medical device inserted within the body, with the added function of being able to use a heating element to actuate the wire ([0105]).
Claim(s) 14 is rejected under 35 U.S.C. 103 as being unpatentable over De Falco in view of Gordon et al. (US 2020/0077991), further in view of van der Linde et al. (US 2017/0361066).
Regarding claim 14, De Falco/Gordon discloses the invention substantially as claimed, as set forth above for claim 1.
De Flaco is silent regarding the material of the wire, specifically the wire comprising a polymer.
However, van der Linde teaches a steerable elongate medical device (abstract, FIG 1) controlled by pull wires (108, [0038, 0047-0049]), wherein the wire comprises a polymer ([0047]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the wire of De Falco to comprise a polymer, as taught by van der Linde, for the purpose of selecting a material commonly known in the art for having the desired structural and flexibility properties for functioning as a pull wire to steer an elongate medical device inserted within the body.
Conclusion
THIS ACTION IS MADE FINAL. 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 BROOKE N LABRANCHE whose telephone number is (571)272-9775. The examiner can normally be reached M-F 8-5.
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/BROOKE LABRANCHE/ Primary Examiner, Art Unit 3771
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