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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 March 12th, 2026 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted March 12th, 2026 has been considered by the Examiner.
Response to Amendment
Applicant’s amendments to the claims have overcome the 112(b) rejections of claims 1 & 10 previously set forth in the Final Office Action mailed November 18th, 2025, however, claims 10 and 11 remain rejected under 112(b), see below.
Response to Arguments
Applicant’s arguments, see pages 6-12, filed March 12th, 2026, with respect to the rejection(s) of claim(s) 1 under 35 U.S.C. 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of newly found prior art that teaches the newly disclosed limitations.
The following new grounds of rejection are set forth:
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 10-11 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.
Regarding claim 10, the claim recites “a proximal end of the expandable assembly” in line 4 and it is unclear if this is the same proximal end of the expandable assembly as recited in claim 1, from which claim 10 depends, or is a different proximal end of the expandable assembly. For examination purposes, these are the same proximal ends and the limitation will be interpreted as “the proximal end of the expandable assembly”.
Regarding claim 10, the claim recites “a distal end of the expandable assembly” in line 5 and it is unclear if this is the same distal end of the expandable assembly as recited in claim 1, from which claim 10 depends, or is a different distal end of the expandable assembly. For examination purposes, these are the same distal ends and the limitation will be interpreted as “the distal end of the expandable assembly”.
Regarding claim 11, the claim recites "a plurality of electrodes" in line 3 and it is unclear if this is the same electrodes as the "electrodes" as recited in claim 1, from which claim 11 depends or different electrodes. For examination purposes, these are the same electrodes and the limitation will be interpreted as "the electrodes".
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3-4, 6 & 10-11 are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Willard et al. (U.S. Pub. No. 20150018818), herein referred to as “Willard”.
Regarding claim 1, Willard teaches a medical apparatus (Abstract: Systems for nerve and tissue modulation are disclosed), comprising:
an insertion tube (outer elongate shaft 102) configured for insertion into a body cavity of a patient ([0030]: the inner and/or outer elongate shafts 104, 102 may be sized and configured to accommodate passage through an intravascular path);
an expandable assembly (expandable assembly 114) connected distally to the insertion tube ([0033]: The proximal end 116 of the basket 114 may be secured to or adjacent to the distal end region 108 of the outer elongate shaft 102) and comprising electrodes (electrode assemblies 124a, 124b), which are configured to apply electrical energy to tissue within the body cavity ([0036]: The modulation system 100 may further include one or more electrode assemblies 124a, 124b positioned on a surface of the expandable basket 114 and/or inner cover 122 for delivering RF energy to a desired treatment region); and
a flexible porous sheath (outer cover 130; [0050]: The outer cover 130 may be made from an elastomeric material, such as, but not limited to: polyurethane, silicone, etc. … the cover material could be a less stretchable material, for example, tetrafluoroethylene (Tfe), polyethylene terephthalate (PET), or fabrics (for example, polyester or polymer coated fabrics); [0052]: the outer cover 130 may be disposed over the electrodes 130 and subsequently removed, such as, but not limited to laser ablation. This may allow for the electrodes 326 to directly contact the vessel wall; wherein this is seen as being porous), which is fitted over the expandable assembly ([0050]: an outer cover or coating 130 disposed on an outer surface of the expandable basket 114 and over the inner cover 122 when so present) and joined to a distal end of the expandable assembly and to a proximal end of the expandable assembly ([0050]: the outer cover 130 may extend from the proximal end 116 to the distal end 118 of the basket 114; [0051]: the outer cover 130 may be adhered to the inner cover 122 and/or basket 114; where this is seen as being joined to distal and proximal ends of the expandable assembly), the flexible porous sheath configured to contact both the tissue within the body cavity and the electrodes so that the electrical energy is applied from the electrodes through the flexible porous sheath to the tissue ([0052]: the outer cover 130 may not extend over the electrodes 126a, 126b of the electrode assemblies 124a, 124b, as shown in FIG. 2D … the outer cover 130 may be disposed over the electrodes 130 and subsequently removed, such as, but not limited to laser ablation. This may allow for the electrodes 326 to directly contact the vessel wall; wherein this is seen as the outer cover contacting both the tissue and the electrodes as it contacts the outer perimeter of the electrode assemblies and facilitates electrical energy application from the electrode assemblies through the outer cover to the tissue).
Regarding claim 3, Willard discloses wherein the flexible porous sheath comprises a braided polymer fiber ([0050]: the cover material could be a less stretchable material, for example, tetrafluoroethylene (Tfe), polyethylene terephthalate (PET), or fabrics (for example, polyester or polymer coated fabrics); wherein a fabric is seen as a braid since both are a woven textile).
Regarding claim 4, Willard discloses wherein the flexible porous sheath is braided as a tube of varying diameter (see Figs. 1A-D where outer cover 130 has a varying diameter).
Regarding claim 6, Willard teaches wherein the expandable assembly comprises one or more irrigation outlets, which are coupled to convey an irrigation fluid from the insertion tube to the tissue through the flexible porous sheath ([0029]: the inner and/or outer elongate shafts 104, 102 may include a separate lumen(s) (not shown) for infusion of fluids, such as saline or dye for visualization or for other purposes such as the introduction of a medical device, and so forth. The fluid may facilitate cooling of the modulation device 100 during the ablation procedure, in addition to the cooling of a body lumen; [0050]: the cover material could be a less stretchable material, for example, tetrafluoroethylene (Tfe), polyethylene terephthalate (PET), or fabrics (for example, polyester or polymer coated fabrics); wherein in a system with a fluid lumen in the elongate shaft with an outer cover comprising pores, this describes a structure capable of conveying irrigation fluid through the porous sheath/outer cover).
Regarding claim 10, Willard teaches wherein the expandable assembly (expandable basket 114) comprises a plurality of resilient spines ([0031]: the basket 114 may be formed from a number of generally longitudinally extending tines), having respective proximal and distal tips (proximal and distal ends of tines of 114), wherein the proximal tips of the plurality of resilient spines are joined mechanically at a proximal end of the expandable assembly ([0033]: The proximal end 116 of the basket 114 may be secured to or adjacent to the distal end region 108 of the outer elongate shaft 102), and the distal tips of the plurality of resilient spines are joined mechanically at a distal end of the expandable assembly ([0033]: The distal end 118 of the basket 114 may be secured to or adjacent to the distal end region 110 of the inner elongate shaft 104), and the plurality of resilient spines bow radially outward against the flexible porous sheath when the expandable assembly is deployed in the body cavity, thereby causing the flexible porous sheath to contact the tissue in the body cavity ([0033]: the basket 114 may be self-expanding. It is contemplated that a self-expanding basket 114 may be maintained in a compressed (or collapsed state) when an external force is placed on the basket 114. The basket 114 may then expand when the external force is released; see Fig. 2C where the outer cover is pushed out/covering the expandable basket 114).
Regarding claim 11, Willard teaches wherein the expandable assembly comprises a balloon membrane (inner cover 122) that includes a plurality of electrodes (electrodes 124a, 124b) disposed radially on an outer surface of the balloon membrane ([0036]: one or more electrode assemblies 124a, 124b positioned on a surface of the expandable basket 114 and/or inner cover 122) and in contact with the flexible porous sheath ([0052]: the outer cover 130 may not extend over the electrodes 126a, 126b of the electrode assemblies 124a, 124b, as shown in FIG. 2D … the outer cover 130 may be disposed over the electrodes 130 and subsequently removed, such as, but not limited to laser ablation. This may allow for the electrodes 326 to directly contact the vessel wall), each electrode of the electrodes being electrically connected to at least one respective conductive member (traces 128a, 128b) extending through the insertion tube ([0058] While not explicitly shown, the electrode assemblies 124a, 124b may be connected to a single control unit or to separate control units (such as control unit 18 in FIG. 1) by electrical conductors 128a, 128b; wherein this connection as shown in Fig. 2B depicts traces 128a, 128b as going through the elongate shaft 102); and wherein the expandable assembly further comprises irrigation pores that extend through the balloon membrane to allow irrigation fluid to flow from the insertion tube through the irrigation pores ([0035]: the cover material could be a less stretchable material, for example, tetrafluoroethylene (Tfe), polyethylene terephthalate (PET), or fabrics (for example, polyester or polymer coated fabrics; [0029]: the inner and/or outer elongate shafts 104, 102 may include a separate lumen(s) (not shown) for infusion of fluids, such as saline or dye for visualization or for other purposes such as the introduction of a medical device, and so forth. The fluid may facilitate cooling of the modulation device 100 during the ablation procedure, in addition to the cooling of a body lumen; wherein in a system with a fluid lumen in the elongate shaft with an inner cover comprising fabric which is porous, this describes a structure capable of conveying irrigation fluid through the porous sheath/inner cover).
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.
Claims 2 & 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Willard as applied to claim 1 above, and further in view of O’Sullivan et al. (U.S. Pub. No. 20050015082, cited in IDS), herein referred to as “O’Sullivan”.
Regarding claim 2, Willard fails to disclose wherein the flexible porous sheath comprises expanded polytetrafluoroethylene (ePTFE).
However, O’Sullivan discloses wherein the flexible porous sheath comprises expanded polytetrafluoroethylene (ePTFE) ([0032]: A particularly suitable material for the porous sleeve 46 is expanded polytetrafluoroethylene (ePTFE)). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the sheath of Willard to comprise expanded polytetrafluoroethylene (ePTFE), as taught by O’Sullivan, for the purpose of the material enabling saline and other fluid to pass and to conform to surface irregularities of the tissue against which the porous electrode is placed (O’Sullivan: [0032]).
Regarding claim 8, Willard fails to disclose wherein the flexible porous sheath contains pores having respective areas between 10 µm2 and 100,000 µm2.
However, O’Sullivan discloses wherein the flexible porous sheath contains pores having respective areas between 10 µm2 and 100,000 µm2 ([0032]: The porosity of the material desirably ranges between about 5 and 50 microns; wherein if the pores are circular and the area of a circle is πr^2 such that (3.14)(5)(5) to (3.14)(50)(50) = 78.5 – 7850 µm2). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the sheath of Willard to have the respective pore areas, as taught by O’Sullivan, for the purpose of the pore size allowing saline and other fluid to pass (O’Sullivan: [0032]).
Additionally, Willard discloses the claimed invention except for wherein the porous sheath contains pores having respective areas between 10 µm2 and 100,000 µm2. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention for the porous sheath to contain pores having respective areas between 10 µm2 and 100,000 µm2, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 9, Willard fails to disclose wherein the respective areas of the pores are between 100 µm2 and 10,000 µm2.
However, O’Sullivan discloses wherein the respective areas of the pores are between 100 µm2 and 10,000 µm2 ([0032]: The porosity of the material desirably ranges between about 5 and 50 microns; wherein if the pores are circular and the area of a circle is πr^2 such that (3.14)(5)(5) to (3.14)(50)(50) = 78.5 – 7850 µm2; wherein this overlaps with the claimed range). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the sheath of Willard to have the respective pore areas, as taught by O’Sullivan, for the purpose of the pore size allowing saline and other fluid to pass (O’Sullivan: [0032]).
Additionally, Willard discloses the claimed invention except for wherein the respective areas of the pores are between 100 µm2 and 10,000 µm2. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention for the respective areas of the pores to be between 100 µm2 and 10,000 µm2, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Willard as applied to claim 1 above, and further in view of Willard (U.S. Pub. No. 20150018817, previously cited), herein referred to as “Willard 2”.
Regarding claim 5, Willard fails to disclose wherein the flexible porous sheath comprises a polymer fiber having a hydrophilic coating.
However, Willard 2 discloses wherein the flexible porous sheath comprises a polymer fiber having a hydrophilic coating ([0027]: Outer layer 36 may include a hydrophilic, hydratable, RF permeable, and/or conductive material … outer layer 36 may include a hydratable polymer that is blended with a non-hydratable polymer such as a non-hydratable polyether block amide (e.g., PEBAX.RTM. 7033 and 7233, commercially available from Arkema) and/or styrenic block copolymers such as styrene-isoprene-styrene). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the sheath of Willard to comprise a polymer fiber having a hydrophobic coating, as taught by Willard 2, for the purpose of enabling the circulation of the conductive fluid may mitigate the temperature rise of the tissue of the blood vessel in contact with the non-virtual electrode areas and compounding a non-hydratable polymer with a hydratable polymer to form outer layer may increase its strength (Willard 2: [0029], [0027]).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Willard as applied to claim 1 above, and further in view of Harlev et al. (U.S. Pat. No. 10105179, previously cited), herein referred to as “Harlev”.
Regarding claim 7, Willard discloses wherein the flexible porous sheath comprises a fabric ([0050]: the cover material could be a less stretchable material, for example, tetrafluoroethylene (Tfe), polyethylene terephthalate (PET), or fabrics (for example, polyester or polymer coated fabrics), but Willard fails to disclose wherein the flexible porous sheath comprises a fabric chosen to permit the irrigation fluid to pass outward through the flexible porous sheath from the one or more irrigation outlets to the tissue while preventing blood from penetrating inward through the flexible porous sheath from the body cavity.
However, Harlev discloses wherein the flexible porous sheath comprises a fabric chosen to permit the irrigation fluid to pass outward through the flexible porous sheath from the one or more irrigation outlets to the tissue while preventing blood from penetrating inward through the flexible porous sheath from the body cavity (Col. 38, lines 42-52: The size and distribution of the openings 170 defined between or through polymeric fibers can allow the irrigation element 128b to act as a selective filter. For example, because blood molecules are substantially larger than water molecules, the size (e.g., the average size) of the openings 170 can be smaller than blood molecules but larger than water molecules. It should be appreciated that such sizing of the openings 170 can permit egress of irrigation fluid from the irrigation element 128b while preventing ingress and, thus, clotting of blood molecules into the irrigation element 128b). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the sheath of Willard to comprise a fabric, as taught by Harlev, for the purpose of permitting egress of irrigation fluid from the irrigation element while preventing ingress and, thus, clotting of blood molecules into the irrigation element (Harlev: Col. 38, lines 49-51).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Abigail M Ziegler whose telephone number is (571) 272-1991. The examiner can normally be reached M-F 8:30 a.m. - 5 p.m. EST.
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/ABIGAIL M ZIEGLER/Examiner, Art Unit 3794
/BEVERLY M FLANAGAN/Primary Examiner, Art Unit 3794
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