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 amendment filed 30 April 2026 has been entered. Claims 1, 3, 5-7, and 13-15 are currently amended. Claims 2, 8-12, and 17-20 are canceled, and claims 21-22 are new. Claims 1, 3-7, 13-16, and 21-22 are pending in the application. Applicant’s amendments to the claims have overcome each and every objection and rejection under 35 U.S.C. 112(b) previously set forth in the Non-Final Office Action mailed 31 October 2025.
Claim Objections
Claim 22 is objected to because of the following informalities: in line 9, “electrically non-conductive disposed” should read --electrically non-conductive and disposed--. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 13-16 and 22 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 13 and 22 each recite the limitation “the distal clamping portion.” There is insufficient antecedent basis for this limitation in the claims. Examiner recommends amending this limitation to read --the distal side clamping portion-- as recited earlier in the claims. Dependent claims 14-16 are necessarily rejected as depending upon a rejected base claim.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claims 1, 3-7, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Arevalos et al. (US PGPub No. 2020/0289196), hereinafter Arevalos, in view of Nezhat (US Patent No. 6,123,701), and further in view of Gutterman (US PGPub No. 2008/0027273).
Regarding claim 1, Arevalos teaches a medical device comprising: an elongated shaft portion (Fig. 1: delivery catheter 201);
and an expansion body that is provided in a distal portion of the shaft portion, the expansion body configured to expand and contract in a radial direction, wherein the expansion body includes a plurality of wire portions that are linked with the shaft portion (Figs. 18A-18C: self-expanding mesh 1803; par. 0188: “a self-expanding (shape memory) mesh 1803o in the shape of a dumbbell […] the discs are constrained within a delivery catheter and unconstrained to permit expansion on either side of the septum 1807”),
and at least one clamping portion that is formed by at least one of the wire portions (Fig. 18C: discs clamping onto septum 1807),
the clamping portion includes an energy transfer element configured to output energy (Figs. 18B-18C: proximal disc of mesh 1803o; par. 0188: “flexible metal loops are mounted on the inward faces (septum-facing sides) of each mesh disc, or alternatively, on around curved face of each disc (set back with respect to the face contacting the septum). In some embodiments, the discs are constrained within a delivery catheter and unconstrained to permit expansion on either side of the septum 1807. In some embodiments, the metal loops act as the RF cathode 1803b and anode 1813b”),
and a back support portion, the back support portion includes a receiving surface that is configured to face the energy transfer element when the expansion body expands (Figs. 18B-18C: distal disc of mesh 1803o),
and the receiving surface is configured to be inclined to be approximately parallel to the energy transfer element, when the energy transfer element moves toward the back support portion (par. 0188: “the discs serve to ensure and maintain parallel alignment of the metal loops with septum”),
wherein the at least one clamping portion includes two outer peripheral portions on both sides in a width direction relative to the back support portion, the width direction being a direction orthogonal to both of an axial direction of the expansion body and the radial direction of the extension body (Fig. 18B: circular shape of memory mesh 1803o orthogonal to axis of catheter, with left and right sides of the circular shape projecting in a width direction orthogonal to a vertical radial direction of the circular shape).
Arevalos does not explicitly teach wherein the back support portion is formed from a plurality of flexible back support wires, each of the plurality of flexible back support wires extending between the two outer peripheral portions that sandwich the back support portion between the two outer peripheral portions. However, in an analogous art, Nezhat teaches a tissue-clamping device with two outer peripheral portions (Figs. 1D-1E: frame structure around electrode 202) with a back support portion formed from a plurality of flexible back support wires, each of the plurality of flexible back support wires extending between the two outer peripheral portions that sandwich the back support portion therebetween (Figs. 1D-1E: conformable mesh electrode structure 202; col 7, lines 29-30: “The conformable electrode structures 202 and 203 comprise metallized elastomeric meshes”), which assures firm engagement and electrode contact with the tissue (col 3, lines 37-41: “it will be desirable to provide flexible, elastic electrodes which may be conformed about the outer periphery of a tissue or organ surface, where the elastic nature of the electrode assures firm engagement and electrode contact”). Nezhat is considered analogous to the claimed invention because it is reasonably pertinent to the problem faced by the inventor, that is, the problem of establishing firm electrode contact with tissue. It would therefore have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to provide the device of Arevalos with a flexible back support portion, as taught by Nezhat, in order to assure firm engagement and contact with tissue, as taught by Nezhat.
The combination does not explicitly teach wherein the plurality of flexible back support wires are discrete from and not interlinked with each other between the two outer peripheral portions such that the plurality of flexible back support wires are independently deformable with respect to each other, the receiving surface being formed by the plurality of flexible back support wires with gaps between adjacent flexible back support wires. However, in an analogous art, Gutterman teaches a surgical device with a tissue support portion having a plurality of flexible support wires that are discrete from and not interlinked with each other such that the plurality of flexible support wires are independently deformable with respect to each other and form a receiving surface with gaps between adjacent wires, and that such a weave pattern permits elastic deformation under load (par. 0095: “the sling 36 may be constructed of a material and/or using a weave pattern that permits elastic deformation under load. For example, sling 36 may comprise a plurality of generally parallel extending filaments which connect for example at each of the end points 38 and 40 of the basket 36”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the device of the combined reference by using the weave pattern taught by Gutterman, that is, with parallel support wires, in order to permit elastic deformation under load, as taught by Gutterman.
Regarding claims 3-4, the combination teaches the device of claim 1 as described previously. Arevalos further teaches wherein the two outer peripheral portions each have a convex shape to an outer side in the width direction, and wherein the two outer peripheral portions each have a circular arc shape that smoothly projects to the outer side in the width direction (Fig. 18B: circular shape of memory mesh 1803o with left and right sides of the circular shape projecting in a convex circular arc shape).
Regarding claim 5, the combination teaches the device of claim 1 as described previously. Arevalos further teaches wherein a maximum width between the two outer peripheral portions that sandwich the back support portion between the two outer peripheral portions in the width direction is larger than a maximum width of the energy transfer element in the width direction (Figs. 18B-18C: maximum width of mesh 1803o wider than maximum width of metal loops 1803b and 1813b).
Regarding claim 6, the combination teaches the device of claim 1 as described previously. Nezhat further teaches wherein the back support portion moves further than the two outer peripheral portions due to a force in the axis direction to be received from the energy transfer element (Fig. 1E: mesh electrode 202 extending beyond frame structure when force is applied for clamping), and it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to configure the back support portion as taught by Nezhat, for the same reasons set forth previously in the rejection of claim 1, that is, to assure firm engagement and contact with tissue.
Regarding claim 7, the combination teaches the device of claim 1 as described previously. Arevalos further teaches wherein the expansion body includes an inner projection portion that projects to an inner side in the radial direction between the energy transfer element and the back support portion; and the maximum width between the two outer peripheral portions that sandwich the back support portion between the two outer peripheral portions in the width direction is larger than a maximum width of the inner projection portion in the width direction (Figs. 18A-18C: maximum width of dumbbell-shaped mesh 1803o wider than the inner connecting portion passing through septum 1807).
Regarding claim 21, the combination teaches the device of claim 1 as described previously. Gutterman further teaches wherein the plurality of flexible back support wires extend between the two outer peripheral portions without crossing each other (par. 0095: “sling 36 may comprise a plurality of generally parallel extending filaments which connect for example at each of the end points 38 and 40 of the basket 36”).
Claims 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over Arevalos in view of Nezhat and further in view of Schecter (US PGPub No. 2011/0213357).
Regarding claim 13, Arevalos in view of Nezhat teaches the limitations of the claim corresponding to claim 1, for the same reasons set forth in the rejection of claim 1. Arevalos further teaches wherein the clamping portion includes a proximal side clamping portion, a distal side clamping portion and an inner projection portion between the proximal side clamping portion and the distal side clamping portion so as to form a valley shape recessed in the radial direction of the expansion body at an axial central portion of the clamping portion (see annotated Figs. 18A-18B: inner projection portion forming a valley shape at arrow, recessed in the radial direction of the mesh at an axial central point between the proximal and distal sides).
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Annotated Figures 18A-18B
The combination does not teach wherein the energy transfer element is an electrode disposed only on one of the proximal side clamping portion and the distal clamping portion, and the receiving surface is electrically non-conductive and disposed on the other of the proximal side clamping portion and the distal clamping portion. However, in an analogous art, Schecter teaches a clamping RF ablation device wherein an electrode is disposed only on one of the clamping side portions, and the receiving surface is electrically non-conductive and disposed on the other of the proximal side clamping portion and the distal clamping portion (Fig. 38: electrodes 625 disposed on only one side of the clamping device). Schecter further teaches that such a configuration provides an RF energy flow parallel to the application of compression force so as to cause localized heating (par. 0071: “a tissue welder device 600 having an offset configuration with electrodes 625 located on only one jaw surface. Electrodes 625 of differing electrical potentials are spaced apart with current flowing substantially planar to the clamped tissue. […] Bipolar radio-frequency energy 620 is conducted through the target tissue 615 to flow in a direction parallel to the application of compression force to the general compressed tissue plane so as to cause localized heating”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the device of the combined reference by placing the energy transfer element on only one clamping side, as taught by Schecter, in order to cause localized heating due to a parallel flow of energy, as taught by Schecter.
Regarding claim 14, the combination teaches the device of claim 13 as described previously. Arevalos further teaches the limitations of claim 14 for the same reasons set forth in the rejection of claim 1.
Regarding claims 15-16, the combination teaches the device of claim 13 as described previously. Nezhat further teaches wherein the at least one flexible back support wire comprises a plurality of back support wires, the plurality of back support wires having both ends fixed to the two outer peripheral portions, and wherein the receiving surface of the back support portion is formed by the plurality of the back support wires with gaps (Fig. 1D: mesh electrode 202 comprising a plurality of wires with gaps between the wires).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Arevalos in view of Nezhat and Gutterman and further in view of Schecter.
Arevalos in view of Nezhat and Gutterman teaches the device of claim 1 as described previously. The combination in view of Schecter further teaches the limitations of claim 22 for the same reasons set forth in the rejection of claim 13.
Response to Arguments
Applicant’s arguments, filed 30 April 2026, with respect to the rejection(s) of claim(s) 1 and 13 under 35 U.S.C. 102(a)(1) and 35 U.S.C. 103, respectively, have been fully considered and are persuasive. Therefore, in light of the amendments to the claims, the previous rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Gutterman and Schecter. As described previously, Gutterman teaches a plurality of flexible support wires that are independently deformable and not interlinked with each other, and Schecter teaches providing an electrode on only one side of an electrosurgical clamping device.
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 DAVINA E LEE whose telephone number is (571)272-5765. The examiner can normally be reached Monday through Friday between 8:00 AM and 5:30 PM (ET).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JOANNE M RODDEN can be reached at (303) 297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/D.E.L./Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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