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 October 27th, 2025 has been entered. Applicant’s amendments to the claims have overcome the 112(b) rejections previously set forth in the Non-Final Rejection mailed August 12th, 2025.
Response to Arguments
Applicant’s arguments, see pages 4-7, filed October 27th, 2025, with respect to the rejection(s) of claim(s) 1-9 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 Therefore, the rejection has been withdrawn.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 claim limitations.
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 1-7 are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Zhou et al. (U.S. Pub. No. 20190030297), herein referred to as “Zhou”.
Regarding claim 1, Zhou teaches a catheter (Abstract: A delivery sheath), comprising:
a first shaft (elastic outer tubular layer 40) configured to be inserted into a body ([0060]: Generally, during use a distal end of the sheath 8 is passed through the skin of the patient and inserted into a vessel, such as the trans-femoral vessel; wherein sheath 8 comprises elastic outer tubular layer 40), the first shaft including a first lumen (initial elastic lumen 58) that extends in an axial direction from a proximal end side toward a distal end side ([0067]: The outer tubular layer 40 defines an initial elastic lumen 58 extending axially through its cylindrical cross-section); and
a second member (longitudinal rods 60) forming, together with a first member (elastic outer tubular layer 40) that is a main constituent member of the first shaft, directly forming an inner circumferential surface defining the first lumen ([0070]: The longitudinal rods 60 extend the length of the outer tubular layer 40 and protrude into the initial elastic lumen 58), the second member having frictional properties lower than frictional properties of the first member ([0069]: The outer tubular layer 40, in one implementation, is constructed of a relatively elastic material … An exemplary material includes NEUSOFT. NEUSOFT is a translucent polyether urethane based material; [0085]: longitudinal rods 60 are comprised of relatively high stiffness materials such as HDPE, fluropolymer and PTFE; see Fig. 5; wherein in view of paragraph [0040] of the instant application’s specification: “The first member (main constituent member of the outer shaft 10) is formed of, for example, nylon or urethane, and the second member (each sub-shaft 101 to 112) is formed of, for example, a fluororesin such as polytetrafluoroethylene (PTFE) or perfluoroalkoxy alkane (PFA)”, Zhou teaches the claimed frictional properties).
Regarding claim 2, Zhou teaches wherein the second member extends in the axial direction ([0070]: The longitudinal rods 60 extend the length of the outer tubular layer 40).
Regarding claim 3, Zhou teaches wherein the second member extends in the axial direction from a proximal end toward a distal end of the first shaft ([0070]: The longitudinal rods 60 extend the length of the outer tubular layer 40).
Regarding claim 4, Zhou teaches wherein a plurality of the second members are disposed along a circumferential direction of the inner circumferential surface ([0070]: elastic outer tubular layer 40 including a plurality of longitudinal rods 60. The longitudinal rods 60 extend the length of the outer tubular layer 40 and protrude into the initial elastic lumen 58. The longitudinal rods 60 are coupled to the outer tubular layer, such as by being co-extruded and/or embedded into the elastic material of the outer tubular layer, as shown in FIG. 6).
Regarding claim 5, Zhou teaches wherein intervals in the circumferential direction between the plurality of second members are substantially constant ([0071]: The longitudinal rods 60 may be circumferentially spaced about the inside surface of the outer tubular layer 60; see Fig. 20).
Regarding claim 6, Zhou teaches wherein the second member projects into the first lumen from the first member ([0070]: The longitudinal rods 60 are coupled to the outer tubular layer, such as by being co-extruded and/or embedded into the elastic material of the outer tubular layer, as shown in FIG. 6).
Regarding claim 7, Zhou teaches wherein the second member includes a fluororesin ([0085]: longitudinal rods 60 are comprised of relatively high stiffness materials such as HDPE, fluropolymer and PTFE).
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 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Zhou as applied to claim 1 above, and further in view of Cheung et al. (U.S. Pub. No. 20120150107, previously cited), herein referred to as “Cheung”.
Regarding claim 8, Zhou discloses a second shaft (longitudinal rods 60), the second shaft including the second member (longitudinal rods 60, multiple shown in Fig. 5), wherein a portion of an outer circumferential surface of the second shaft forms, together with the first member, the inner circumferential surface defining the first lumen ([0070]: The longitudinal rods 60 extend the length of the outer tubular layer 40 and protrude into the initial elastic lumen 58).
But Zhou fails to disclose the second shaft including a second lumen extending in the axial direction.
However, Cheung discloses a second shaft (conduits 36) including a second lumen (lumen of conduit 36) extending in the axial direction ([0032]: The one or more conduits 36 may be configured to transport fluid, sense parameters (e.g. pressure, temperature, vacuum, etc.) and/or route electrical wires and/or sensors through the catheter shaft 20; wherein this describes a structure (the conduits) extending in an axial direction). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the second shaft of Zhou to include a lumen, as taught by Cheung, for the purpose of the lumen enabling the second shaft to transport fluid, sense parameters (e.g. pressure, temperature, vacuum, etc.) and/or route electrical wires and/or sensors through the catheter shaft (Cheung: [0032]).
Regarding claim 9, Zhou fails to disclose a balloon attached to the distal end side of the first shaft, the balloon configured to be inflatable by a fluid supplied from a proximal end side of the second shaft into the second lumen.
However, Cheung discloses a balloon (balloon assembly 26) attached to the distal end side of the first shaft ([0023]: a balloon assembly 26 is disposed about the distal region 22 of catheter shaft 20), the balloon configured to be inflatable by a fluid supplied from a proximal end side of the second shaft into the second lumen ([0032]: The one or more conduits 36 may be configured to transport fluid, sense parameters (e.g. pressure, temperature, vacuum, etc.) and/or route electrical wires and/or sensors through the catheter shaft 20. For example, the one or more conduits 36 can include a pressure monitoring lumen for controlling and/or monitoring the pressure with the balloon assembly 26, a vacuum lumen, a supply lumen, and/or any other suitable lumen, as desired). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the catheter of Zhou to include a balloon, as taught by Cheung, for the purpose of treatment may be effected by positioning the distal end of the balloon adjacent a target location in a body and the balloon enabling radial engagement of the soft tissue (Cheung: [0044]).
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 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
/THOMAS A GIULIANI/Primary Examiner, Art Unit 3794