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 7/22/2026 has been entered. Claims 1-3 and 6-20 are pending in the application.
Claim Objections
Claims 1 and 8 are objected to because of the following informalities:
Regarding claim 1, both instances of “the curved surfaces” should be corrected to “the two curved surfaces” for claim language consistency
Regarding claim 8, “a longitudinal” should be corrected to “the longitudinal” for claim language consistency. 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.
Claim 8 is 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 8, the limitation of “a longitudinal axis defined by the distal section of the catheter” renders the claim unclear. Claim 1, which claim 8 is dependent on, introduces the limitation of “a longitudinal axis of the catheter”. The Examiner is unsure if “a longitudinal axis” of claim 8 is intended to be in reference to “a longitudinal axis” of claim 1 or a new, separate longitudinal axis. Based on the drawings and specification, there appears to be one longitudinal axis L-L ([0058] & Fig. 1). For purposes of examination, the Examiner is interpreting “a longitudinal axis” of claim 8 to be in reference to the axis of claim 1.
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.
Claim(s) 1-2, 8, 11, and 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gunderson (US 20080125752 A1), and further in view of McCullagh (US 20050149171 A1).
Regarding claim 1, Gunderson discloses a catheter (catheter 400, Fig. 11) comprising: a braid extending through a distal section of the catheter and comprising clockwise strands and counter-clockwise strands (braid 454 comprising a number of individual wires woven together, the individual wires seen forming clockwise and counter clockwise strands, [0019] and [0038] & Fig. 11; braid 454 adjacent to distal tip 464, [0038] & Fig. 11; “braid 454 that can be similar in form and function to reinforcement member 22.”, [0036]); a plurality of braid terminations, each braid termination of the plurality of braid terminations joining a distal portion of a clockwise strand to a distal portion of a counter-clockwise strand (welds 26, synonymous to welds 456, specifically welds 456e, joining together adjoining wire filaments that form the braid 22, synonymous to braid 454, at their distalmost point, see [0025] and [0036] & Fig. 3 and 11); an inner liner disposed within the braid (liner 453, synonymous to liner 20, [0036] & Fig. 11); and an outer jacket disposed over the braid (outer surface 462 made of members 458a-e, [0038] & Fig. 10-11), wherein the clockwise strand and the counter-clockwise strand overlap each other at a distal braid junction located proximal of the plurality of braid terminations (the individual wires woven together forming braid 454 overlap each other at a junction located proximal of welds 456e, see Fig. 2-3 and 11; “braid 454 that can be similar in form and function to reinforcement member 22”, [0036], layer 22 being “one or more wires or wire filaments… woven together into a braid” ([0021]) with “intersecting or adjoining wire filaments that form braid 22“ ([0025]); the wires of braid 22 seen overlapping each another in Figs. 2-3 and 6 at a junction located proximal to weld 26).
However, Gunderson fails to explicitly disclose a catheter wherein each braid termination of the plurality of braid terminations comprises a sleeve over the distal portion of the clockwise strand and over the distal portion of the counter-clockwise strand, and wherein the sleeve comprises a crimped B-shape comprising a flat surface on one face of the sleeve and two curved surfaces on an opposite face of the sleeve, wherein the sleeve further comprises ends terminating the curved surfaces between the distal portion of the clockwise strand and the distal portion of the counter-clockwise strand, and wherein the curved surfaces are immediately adjacent the ends of the sleeve.
However, McCullagh teaches a stent made of braided wires (stent 10, see [0005]) wherein each braid termination of the plurality of braid terminations (securement member 12, [0039]-[0040] and [0047] & Fig. 2 and 4) comprises a sleeve over the distal portion of the clockwise strand and over the distal portion of the counter-clockwise strand (securement member 12 being a band surrounding the distal portions of portions 14 and 16, [0040]-[0041] and [0047] & Fig. 2 and 4; portions 14 and 16 are potions of stent member 11 which are being interpreted as distal potions of clockwise and counterclockwise strands), and
wherein the sleeve comprises a crimped B-shape comprising a flat surface on one face of the sleeve and two curved surfaces on an opposite face of the sleeve (securement member 12 comprising a B-shape with a flat surface on the outer face of member 12 and two curved surfaces on the inside face, the inside face being opposite the outer face, of member 12, seam 45 separating the two curved surfaces, see annotated Fig. 4 below, structures noted as “Curved Surface 1”, “Curved Surface 2”, and “Flat Surface”),
wherein the sleeve further comprises ends terminating the curved surfaces between the distal portion of the clockwise strand and the distal portion of the counter-clockwise strand (two curved surfaces terminating on top of seam 45, top of seam 45 being between portions 14 and 16, see annotated and magnified Fig. 4a below of McCullagh, structures noted as “End 1” and End 2” separated by a line down the middle of seam 45), and wherein the curved surfaces are immediately adjacent the ends of the sleeve (“Curved Surface 1” and “Curved Surface 2” are immediately adjacent “End 1” and “End 2” as the two curved surfaces terminate at the two ends, see annotated Fig. 4a below).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the braid terminations of Gunderson with McCullagh to include a sleeve over the distal portion of the clockwise strand and over the distal portion of the counter-clockwise strand, wherein the sleeve comprises a crimped B-shape comprising a flat surface on one face of the sleeve and two curved surfaces on an opposite face of the sleeve, wherein the sleeve further comprises ends terminating the curved surfaces between the distal portion of the clockwise strand and the distal portion of the counter-clockwise strand, and wherein the curved surfaces are immediately adjacent the ends of the sleeve,
since such a modification would provide structure to improve peel, shear, tensile, and radial strength over welds and yield predictable results pertaining to wire connection (see [0008] and [0039]-[0040] and [0045] of McCullagh). As modified, securement members 12 of McCullagh would be provided in place of, or together with, welds 456e of Gunderson (see [0049] of McCullagh). As combined, the distal portions of the individual wires woven together forming braid 454 would be oriented parallel to a longitudinal axis of the catheter (see Fig. 10-11 of Gunderson and Fig. 2 of McCullagh; portions 14 and 16 of stent 10 arranged adjacent to each other, [0040] of McCullagh, and oriented parallel to a longitudinal axis of stent 10, see Fig. 2 of McCullagh). Further, as combined, the junction at which the individual wires of braid 454 woven together overlap each other would remain positioned proximal of securement members 12.
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Regarding claim 2, Gunderson discloses all the limitations of claim 1. Gunderson further discloses the catheter wherein an inner diameter of the distal section of the catheter is expandable when the distal section is unconstrained and compressible when the distal section is constrained (polymeric members 458, which make up outer surface 462, made of a flexible material, such as silicone, would allow of the pinching or squeezing of the distal tip 464 of catheter 400, [0020] and [0037]-[0038] & Fig. 11; sheath 24 synonymous to outer surface 462; the pinching or squeezing of distal tip 464 resulting in the inner diameter compressing and expanding).
Regarding claim 8, Gunderson discloses all the limitations of claim 1. Gunderson, as modified, further discloses the catheter wherein the distal portion of the clockwise strand and the distal portion of the counter-clockwise strand are each oriented parallel to a longitudinal axis defined by the distal section of the catheter (as modified, the distal portions of the individual wires woven together forming braid 454 would be oriented parallel to a longitudinal axis defined by the distal section of the catheter, see Fig. 10-11 of Gunderson and Fig. 2 of McCullagh; portions 14 and 16 of stent 10 arranged adjacent to each other, [0040] of McCullagh, and oriented parallel to a longitudinal axis of stent 10, see Fig. 2 of McCullagh).
Regarding claim 11, Gunderson discloses all the limitations of claim 1. However, Gunderson fails to explicitly disclose the catheter wherein each braid termination of the plurality of braid terminations comprises radiopaque material.
However, McCullagh teaches a stent made of braided wires ([0005]) wherein each braid termination of the plurality of braid terminations comprises radiopaque material (securement member 12 made of radiopaque materials, [0015] and [0047]).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the braid terminations of Gunderson with McCullagh to include a securement member comprising radiopaque material since such a modification would provide structure to improve peel, shear, tensile, and radial strength over welds while providing enhanced visibility of the catheter and yield predictable results pertaining to wire connection and visibility (see [0008], [0015], [0039]-[0040], and [0047] of McCullagh).
Regarding claim 13, Gunderson discloses all the limitations of claim 1. Gunderson further discloses the catheter wherein the clockwise strands and/or the counter-clockwise strands comprise radiopaque material (reinforcement member 22, which is synonymous to braid 454, including radiopaque material, see [0023], [0021], and [0036]), and wherein the clockwise strands and/or the counter-clockwise strands comprise memory shape material (reinforcement member 22 made of nitinol, [0022]).
Regarding claim 14, Gunderson discloses all the limitations of claim 1. Gunderson, as modified, further discloses the catheter wherein each braid termination of the plurality of braid terminations comprises a laser weld (welds 456 can be defined using laser spot welding, [0029] & Fig. 11; welds may be provided with securement member 12, see [0049]-[0050] & Fig. 4; in this configuration, welds 456e and securement members 12 are being interpreted as the braid terminations).
Regarding claim 15, Gunderson discloses all the limitations of claim 1. However, Gunderson fails to explicitly disclose the catheter wherein each braid termination of the plurality of braid terminations comprises adhesive. However, McCullagh teaches that “[t]he various strength characteristics of the connection region 20 may be further enhanced by providing additional securement mechanism(s) between the crimping member 12 and the adjacent portions of the stent 10. Such mechanism may include additional bonds between the adjacent portions 14, 16, and/or 18, etc, such as by application of one or more adhesives…” ([0049]). Securement members 12 may comprise adhesives.
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the braid terminations of Gunderson with McCullagh to include a securement member comprising adhesive since such a modification would provide structure to improve peel, shear, tensile, and radial strength over welds while providing additional securement mechanisms between the securement member and the adjacent wire portions to improve strength characteristics and yield predictable results pertaining to wire connection (see [0008], [0039]-[0040], and [0049] of McCullagh).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gunderson (US 20080125752 A1), in view of McCullagh (US 20050149171 A1), and further in view of Cattaneo (WO 2011066962 A1).
Regarding claim 3, Gunderson, as modified, discloses all the limitations of claim 1. Gunderson further discloses the braid 454 as being formed on liner 453 ([0036] and [0021]) and that “[t]he assembly depicted in FIG. 10 can be heated so that polymeric members [458a-458e] and/or liner 453 reflow and secure with braid 454.” ([0037]). As modified, securement members 12, replacing or included with welds 456e, would be provided between outer surface 462 and liner 453, like welds 456e ([0036]-[0037] & Fig. 10-11).
However, Gunderson does not explicitly disclose the flat surface faces outward such that the flat surface is adjacent to the outer jacket and the two curved surfaces face inward such that the two curved surfaces are adjacent to the inner liner, or the flat surface faces inward such that the flat surface is adjacent to the inner liner and the two curved surfaces face outward such that the two curved surfaces are adjacent to the outer jacket.
However, Cattaneo teaches a braided medical device (abstract) comprising a crimped sleeve 18a crimping two parallel wires portions of the medical device together assuming a configuration to advantageously reduce wall thickness (see [0066] and Fig. 3 of Cattaneo).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the catheter of Gunderson, as modified, with Cattaneo to include the flat surface faces outward such that the flat surface is adjacent to the outer jacket and the two curved surfaces face inward such that the two curved surfaces are adjacent to the inner liner, or the flat surface faces inward such that the flat surface is adjacent to the inner liner and the two curved surfaces face outward such that the two curved surfaces are adjacent to the outer jacket since such a modification would advantageously reduce the wall thickness of the catheter (see [0066] of Cattaneo) considering the securement member 12 is wider than it is tall, as seen in Fig. 4 of McCullagh.
As modified, the securement member 12 would be placed with the flat surface facing inward such that the flat surface would be adjacent to liner 453 and the two curved surfaces would be next to, or adjacent, outer surface 462, or securement member 12 would be placed with the flat surface facing outward such that the flat surface would be adjacent to outer surface 462 and the two curved surfaces would be next to, or adjacent, liner 453. Both configurations would advantageously reduce the wall thickness of the catheter.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gunderson (US 20080125752 A1), in view of McCullagh (US 20050149171 A1), and further in view of Tassoni (US 20210290896 A1).
Regarding claim 12, Gunderson discloses all the limitations of claim 1. However, Gunderson fails to explicitly disclose the catheter wherein the braid has a greater braid pattern density in a proximal section of the catheter compared to a braid pattern density in the distal section of the catheter.
However, Tassoni teaches a catheter (catheter 10 including shaft 12, [0044] & Fig. 1 and 3) wherein the braid (first and second braided region 26 and 28, [0057] & Fig. 3) has a greater braid pattern density in a proximal section of the catheter compared to a braid pattern density in the distal section of the catheter (first braided region 26 being proximal to second braided region 28 and having a greater braid pattern density, see [0057] & Fig. 3; the pitch angle of the braided regions may also differ, see [0055]-[0056]).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the catheter of Gunderson with Tassoni to include the braid having a greater braid pattern density in a proximal section of the catheter compared to a braid pattern density in the distal section of the catheter since such a modification would allow for the customization of various performance characteristics along the length of the catheter including flexibility and tensile strength and yield predictable results pertaining to braid pattern creation (see [0004] and [0052]-[0053] of Tassoni).
Response to Arguments
Applicant's arguments filed 7/22/2026 have been fully considered but they are not persuasive.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
In the instant case, McCullagh provides guidance and motivation for using a sleeve instead of, or in conjunction with, a weld. McCullagh teaches that including a securement sleeve would provide structure to improve peel, shear, tensile, and radial strength over welds and yield predictable results pertaining to wire connection (see [0008], [0039]-[0040], [0049] of McCullagh). McCullagh teaches that welds alone, like welds 456 of Gunderson, may “be weak as the welds sometimes yield when subjected to handling.” ([0008] of McCullagh).
In response to Applicant’s arguments that Gunderson does not disclose that the clockwise and counterclockwise strands overlap, the Examiner finds that braid 454 is disclosed as a braid, a braid being a length of something formed of strands woven, or intertwined, together. Braid 454 is also disclosed as being similar in form and function to reinforcement member 22 ([0036]). Figs. 2-3 and 6 illustrating the wires of braid 22 overlapping each other at a junction located proximal to weld 26.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Boismier (US-20050137519-A1) teaches a clockwise strand and a counter-clockwise strand of a catheter braid overlapping each other at a distal braid junction (reinforcing layer 52 made of first filament 56 and second filament 58 woven together, creating overlap at a crossover point 57, [0031]-[0034] & Fig. 4). Inukai (US-20190192812-A1) teaches strands overlapping each other at a distal braid junction ([0019] and [0060] & Fig. 3).
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 MARTIN ADAM RADOMSKI whose telephone number is (571)272-2703. The examiner can normally be reached Monday-Friday: 7:30-4:30 CT.
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/MARTIN A RADOMSKI/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
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