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 February 27th 2026 has been entered. Claims 1-6 and 7-20 are pending in the application. Applicant’s amendments to the Claims have overcome each and every objection and the 112(b) rejection previously set forth in the Non-Final Office Action mailed November 28th 2025.
Claim Objections
Claims 1 and 11 are objected to because of the following informalities:
Regarding claim 1, “and distal tip” should be corrected to “and the distal tip” and “elongation of catheter” should be corrected to “elongation of the catheter” for claim language consistency.
Regarding claim 11, “and distal tip” should be corrected to “and the distal tip” for claim language consistency.
Appropriate correction is required.
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) 1-5, 9, 11, and 13-15is/are rejected under 35 U.S.C. 103 as being unpatentable over Salahieh (US 20080188928 A1), in view of Neumann (WO 2022081710 A1), and further in view of Vale (US 20210275197 A1).
Regarding claims 1-3, Salahieh discloses a catheter (sheath 18, [0043] & Fig. 1A) comprising: a proximal elongate shaft comprising a longitudinal axis (sheath 18 being an elongate shaft defined by inner liner 36 having a longitudinal axis, see [0045] & Fig. 1A-3), a distal end (sheath 18 having a distal end, [0044]-[0045] & Fig. 1A-3), and a shaft braid (wire braid 34, [0045] & Fig. 1B); a distal tip section comprising a tip braid (“The wire braid is preferably not so stiff, however, as to prohibit the distal end from expanding.... If a wire braid is used for structural support in a distal section, it can have different properties from the wire braid used in a proximal section.”, [0045]; the wire braid in the distal section may be interpreted as the tip braid, Fig. 1B; alternatively, the wire braid 34 wrapping may differ in different sections along the sheath length, region R1 and R2, [0046] & Fig. 4; region R1 may be interpreted as the tip braid); an outer jacket disposed around the elongate shaft and tip section (outer liner 38 being a polymer jacket disposed around the inner liner 36 and distal end of braid 34, [0045] & Fig. 1B); and one or more metallic spines extending at least partially along an axial length of the catheter (axial wires 32, which may be metal alloys such as stainless steel or Nitinol, extending along the axial length of sheath 18, [0045] & Fig. 1A-3), the one or more metallic spines inhibiting tensile elongation of catheter (wires 32 disclosed as providing axial stiffness and described as stiffeners, abstract, [0044]-[0045] and [0061]); and wherein the tip braid is formed monolithically with wires of the shaft braid (wire braid 34 forming the tip braid and the shaft braid, [0045]-[0046] & Fig. 1B and 4),
wherein at least one of the one or more metallic spines comprises a proximal portion (axial wires 32 having a proximal portion extending proximally from distal loop 33, see Fig. 3) and a distal portion (distal loop 33 defining the distal portion of wires 32, [0046] & Fig. 3), and wherein the distal portion forms a spine hoop in the tip braid (distal potion of axial wires 32 forming loop 33, with loop 33 seen disposed in the distal section of sheath 18, [0046] & Fig. 3; “The distal ends of the wires may be staggered, even or looped.”, [0061]) that is positioned adjacent the tip braid such that the spine hoop reinforces the tip braid (loop 33 may be interpreted as positioned next to, or adjacent, the distal section of wire braid 34, or region R1, [0045]-[0046] & Fig. 1-4; axial wires 32, including loop 33, are configured to provide stiffness to the structure of the sheath, such as braid 34, see abstract, [0045]-[0046], and [0061] & Fig. 3; since loop 33 is positioned adjacent the distal end of braid 34, loop 33 may be interpreted as strengthening, or reinforcing, the distal end of braid 34).
The Examiner notes that Salahieh discloses that “Regions of radial compliance can be achieved by varying the wire braid density... the wire wrapping (e.g., density of wrapping turns, thickness of wrapping wire) may differ in different sections of the sheath length, as well as the distribution and/or density of the axial wires in different sheath sections as well. ([0046] of Salahieh). Axial wires 32 provide axial stiffness and the distribution and/or density of braid 34 determines radial compliance.
However, Salahieh fails to explicitly disclose the tip braid terminating in distal hoops, wherein the distal hoops of the tip braid are formed monolithically with wires of the shaft braid, and a plurality of outer jackets, and wherein the distal portion forms a spine hoop in the tip braid that is positioned adjacent one or more of the distal hoops of the tip braid such that the spine hoop reinforces the one or more of the distal hoops of the tip braid.
However, Neumann teaches a catheter (expandable sheath 100, being an integral part of guide catheter 10, having a central lumen 112, [079]-[080] & Fig. 1, 3-5B, 8, and 24) comprising a tip braid terminating in distal hoops (the distal end portion of layer 104 at a distal end is being interpreted as the tip braid, in which portions 150 of filaments 110 are bent to form loops 152, [0127] & Fig. 24), wherein the distal hoops of the tip braid are formed monolithically with wires of the shaft braid (filaments 110 form loops 152 and the remainder of braided layer 104, [085] and [0127] & Fig. 4-5B and 24).
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 tip braid of Salahieh with Neumann to include the tip braid terminating in distal hoops, wherein the distal hoops of the tip braid are formed monolithically with wires of the shaft braid, since such a modification would decrease the number of filaments in the braid in the distal direction, which can increase the radial flexibility of the braid (see [0127] of Neumann).
As modified, the tip braid of Salahieh can be formed in the configuration taught in Neumann, with the tip braid terminating in hoops, the hoops being offset from each other and the number of filaments decreasing in a distal direction. As combined, loop 33 of axial wire 32 of Salahieh would be positioned next to, or adjacent, one or more of the distal hoops formed by wire braid 34 in the distal tip section (see [0046] & Fig. 3 of Salahieh and Fig. 24 of Neumann). Loop 33 would continue reinforcing the adjacent structure of the sheath, which, as modified, includes the distal braid hoops formed by wire braid 34.
Further, Vale teaches a catheter (catheter 110, [0077] & Fig. 4A) comprising: a plurality of outer jackets (series of polymer jackets 238, [0111] & Fig. 9B). 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 Salahieh, as modified, with Vale to include a plurality of outer jackets since such a modification would “give distinct pushability and flexibility characteristics to different sections of the tubular portion of the catheter” and yield predictable results pertaining to catheter flexibility (see [0111] of Vale).
Regarding claim 4, Salahieh, as modified, discloses all the limitations of claim 1. Salahieh further discloses the catheter wherein at least one of the one or more metallic spines is interwoven with the shaft braid (axial wires 32 woven into the braided wire layer, [0045]).
Regarding claim 5, Salahieh, as modified, discloses all the limitations of claim 1. Salahieh further discloses the catheter wherein at least a part of the proximal portion comprises two or more adjacent parallel strands (the proximal potion of axial wires 32 seen comprising two adjacent parallel strands, see Fig. 3).
Regarding claim 9, Salahieh, as modified, discloses all the limitations of claim 1. Salahieh further discloses the catheter wherein the one or more metallic spines are external to the shaft braid (axial wires 32 may be laid to the outer surface of the braided wire layer 34, see [0045]).
Regarding claim 11, Salahieh discloses a catheter (sheath 18, [0043] & Fig. 1A) comprising: an elongate tube comprising a longitudinal axis (sheath 18 being an elongate tube defined by inner liner 36 having a longitudinal axis, see [0045] & Fig. 1A-3) and a shaft braid (wire braid 34, [0045] & Fig. 1B); a distal tip section comprising a tip braid (“The wire braid is preferably not so stiff, however, as to prohibit the distal end from expanding.... If a wire braid is used for structural support in a distal section, it can have different properties from the wire braid used in a proximal section.”, [0045]; the wire braid in the distal section may be interpreted as the tip braid, Fig. 1B; alternatively, the wire braid 34 wrapping may differ in different sections along the sheath length, region R1 and R2, [0046] & Fig. 4; region R1 may be interpreted as the tip braid); an outer jacket disposed around the elongate tube and distal tip section (outer liner 38 being a polymer jacket disposed around the inner liner 36 and distal end of braid 34, [0045] & Fig. 1B);
and one or more polymeric spines extending at least partially along an axial length of the catheter (axial wires 32, which may be a polymer filament, extending along the axial length of sheath 18, [0045] & Fig. 1A-3), the one or more polymeric spines inhibiting tensile elongation of the catheter (wires 32 disclosed as providing axial stiffness and described as stiffeners, abstract, [0044]-[0045] and [0061]);
wherein at least one of the one or more polymeric spines comprises a proximal portion (axial wires 32 having a proximal portion extending proximally from distal loop 33, see Fig. 3) and a distal portion (distal loop 33 defining the distal portion of wires 32, [0046] & Fig. 3), and wherein the distal portion forms a spine hoop in the tip braid (distal potion of axial wires 32 forming loop 33, with loop 33 seen disposed in the distal section of sheath 18, [0046] & Fig. 3; “The distal ends of the wires may be staggered, even or looped.”, [0061]) that is positioned adjacent the tip braid such that the spine hoop reinforces the tip braid (loop 33 may be interpreted as positioned next to, or adjacent, the distal section of wire braid 34, or region R1, [0045]-[0046] & Fig. 1-4; axial wires 32, including loop 33, are configured to provide stiffness to the structure of the sheath, such as braid 34, see abstract, [0045]-[0046], and [0061] & Fig. 3; since loop 33 is positioned adjacent the distal end of braid 34, loop 33 may be interpreted as strengthening, or reinforcing, the distal end of braid 34).
The Examiner notes that Salahieh discloses that “Regions of radial compliance can be achieved by varying the wire braid density... the wire wrapping (e.g., density of wrapping turns, thickness of wrapping wire) may differ in different sections of the sheath length, as well as the distribution and/or density of the axial wires in different sheath sections as well. ([0046] of Salahieh). Axial wires 32 provide axial stiffness and the distribution and/or density of braid 34 determines radial compliance.
However, Salahieh fails to explicitly disclose a shaft braid comprising a first set of helical wires braided with a second set of helical wires, a tip braid with distal hoops at a distal end, a plurality of outer jackets disposed around the elongate tube and distal tip section;
wherein the first set of helical wires of the shaft braid invert proximally to form the second set of helical wires of the shaft braid, wherein the distal hoops of the tip braid are formed monolithically with the first set of helical wires and the second set of helical wires of the shaft braid, and wherein the distal portion forms a spine hoop in the tip braid that is positioned adjacent one or more of the distal hoops of the tip braid such that the spine hoop reinforces the one or more of the distal hoops of the tip braid.
However, Neumann teaches a catheter (expandable sheath 100, being an integral part of guide catheter 10, having a central lumen 112, [079]-[080] & Fig. 1, 3-5B, 8, and 24) comprising a shaft braid comprising a first set of helical wires braided with a second set of helical wires (second layer 104 being a braided layer made of a plurality of filaments 110 braided together, [085] & Fig. 4-5B; “The braided layer 104 can have any desired number of filaments 110, which can be oriented and braided together along any suitable number of axes. For example, with reference to FIG. 5B, the filaments 110 can include a first set of filaments 110A oriented parallel to a first axis A, and a second set of filaments 110B oriented parallel to a second axis B. The filaments 110A and 110B can be braided together in a biaxial braid”, [085]; alternatively, a first portion of the first set of filaments 110A can be interpreted as the first set of helical wires and a second portion of the first set of helical wires 110A, the portion which “extend[s] back in the opposite direction”, can be interpreted as the second set of helical wires, [0127] & Fig. 24),
a tip braid with distal hoops at a distal end (the distal end portion of layer 104 at a distal end is being interpreted as the tip braid, in which portions 150 of filaments 110 are bent to form loops 152, [0127] & Fig. 24), wherein the first set of helical wires of the shaft braid invert proximally to form the second set of helical wires of the shaft braid (“…an end portion (e.g., a distal end portion) of another aspect of the braided layer 104 in which portions 150 of the filaments 110 are bent to form loops 152, such that the filaments loop or extend back in the opposite direction along the sheath”, [0127] & Fig. 24; a first portion of the first set of filaments 110A can be interpreted as the first set of helical wires and a second portion of the first set of helical wires 110A, the portion which “extend[s] back in the opposite direction”, can be interpreted as the second set of helical wires); and
wherein the distal hoops of the tip braid are formed monolithically with the first set of helical wires and the second set of helical wires of the shaft braid (loops 152 formed with filaments 110, [0127] and [085] & Fig. 5B and 24).
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 Salahieh with Neumann to include a shaft braid comprising a first set of helical wires braided with a second set of helical wires, a tip braid with distal hoops at a distal end, wherein the first set of helical wires of the shaft braid invert proximally to form the second set of helical wires of the shaft braid, wherein the distal hoops of the tip braid are formed monolithically with the first set of helical wires and the second set of helical wires of the shaft braid, since such a modification would decrease the number of filaments in the braid in the distal direction, which can increase the radial flexibility of the braid (see [0127] of Neumann). Neumann teaches a first set of helical wires braided with a second set of helical wires and a tip braid with distal hoops at a distal end to be an art effective configuration for a catheter shaft braid configured to have radial compliance ([085]-[086] and [0127] of Neumann). The Examiner also notes that Neumann teaches cord(s) 130 configured to “prevent axial elongation of the braided layer 104” ([0103] of Neumann).
As modified, the tip braid of Salahieh can be formed in the configuration taught in Neumann, with the tip braid terminating in hoops, the hoops being offset from each other and the number of filaments decreasing in a distal direction. As combined, loop 33 of axial wire 32 of Salahieh would be positioned next to, or adjacent, one or more of the distal hoops formed by wire braid 34 in the distal tip section (see [0046] & Fig. 3 of Salahieh and Fig. 24 of Neumann). Loop 33 would continue reinforcing the adjacent structure of the sheath, which, as modified, includes the distal braid hoops formed by wire braid 34.
Further, Vale teaches a catheter (catheter 110, [0077] & Fig. 4A) comprising: a plurality of outer jackets (series of polymer jackets 238, [0111] & Fig. 9B). 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 Salahieh, as modified, with Vale to include a plurality of outer jackets since such a modification would “give distinct pushability and flexibility characteristics to different sections of the tubular portion of the catheter” and yield predictable results pertaining to catheter flexibility (see [0111] of Vale).
Regarding claim 13, Salahieh, as modified, discloses all the limitations of claim 11. The limitation of “wherein at least a portion of the one or more polymeric spines is laminated with the outer jackets” is considered to be a product-by-process limitation. A product-by-process limitation adds no patentable distinction to the claim, and is unpatentable if the claimed product is the same as a product of the prior art. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process, MPEP 2113. In the instant case, Salahieh discloses that “The outer liner can be used to hold the axial wire in place” ([0045]).
The Examiner also notes that Neumann teaches that cords 130 are used in combination with outer layer 108 (see [0104]) and “the polymeric layers 102 and 108 can be adhered or laminated to each other… between the filaments 110 in the open spaces 136 defined by the unit cells 134”(see [097] & Fig. 10A).
Regarding claim 14, Salahieh, as modified, discloses all the limitations of claim 11. The limitation of “wherein at least a portion of the one or more polymeric spines is coextruded with at least one of the outer jackets” is considered to be a product-by-process limitation. A product-by-process limitation adds no patentable distinction to the claim, and is unpatentable if the claimed product is the same as a product of the prior art. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process, MPEP 2113. In the instant case, Salahieh discloses that “The outer liner can be used to hold the axial wire in place” ([0045]).
Regarding claim 15, Salahieh, as modified, discloses all the limitations of claim 11. Salahieh further discloses the catheter wherein at least one of the one or more polymeric spines is interwoven with the shaft braid (“axial wires 32 may be woven into the braided wire layer”, [0045] & Fig. 1-4).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Salahieh (US 20080188928 A1), in view of Neumann (WO 2022081710 A1), in view of Vale (US 20210275197 A1), and further in view of Gilson (US 20020049467 A1).
Regarding claim 7, Salahieh, as modified, discloses all the limitations of claim 1. Salahieh further discloses the catheter wherein at least a portion of the one or more metallic spines extends the entire axial length of the catheter (axial wires 32 seen extending the entire axial length of sheath 18, see Fig. 2-3; additionally, the disclosure reciting “Where there are multiple wires 32a, 32b, 32c or filaments, the wires may not be continuous from the proximal end to the distal end” (see [0046]) implies when there is one wire, like the embodiment of Fig. 3 which is relied upon, that the wire is continuous and extends the entire axial length from the proximal end to the distal end).
However, Salahieh fails to explicitly disclose the catheter wherein at least a portion of the one or more metallic spines comprises a non-circular cross section. However, Gilson teaches a catheter (delivery catheter 2, [0197] & Fig. 2) wherein at least a portion of the one or more metallic spines comprises a non-circular cross section (high tensile elements 21, made of steel wires, seen having a rectangular cross section, see [0206] & Figs. 4A and 12A).
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 spines of Salahieh, as modified, with Gilson to include the spines comprising a non-circular cross section since Gilson teaches this to be an art effective configuration for metallic spines extending axially along the length of a catheter, providing the outer shaft with high tensile modulus (minimal stretch), like axial wires 32 of Salahieh (see [0206] of Gilson).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Salahieh (US 20080188928 A1) in view of Neumann (WO 2022081710 A1), in view of Vale (US 20210275197 A1), and further in view of Truckai (US 5176660 A).
Regarding claim 12, Salahieh, as modified, discloses all the limitations of claim 11. However, Salahieh fails to explicitly disclose the catheter wherein at least a portion of the one or more polymeric spines comprises a composition of at least one of high-density polyethylene, poly ether ketone, ultra-high molecular weight polyethylene, aromatic polyamide, LCP liquid crystal polymer, Nylon, or thermoset liquid-crystalline polyoxazole.
However, Truckai teaches a catheter comprising: one or more polymeric spines, wherein at least a portion of the one or more polymeric spines comprises a composition of nylon (reinforcing filaments 32 may be made of nylon, see Col 4 lines 62-66 & Fig. 4). 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 polymeric spines of Salahieh, as modified, with Truckai to include polymeric spines made of nylon since Truckai teaches nylon to be an art effective material for a reinforcing filament extending longitudinally to provide stiffness for a catheter (see Col 4 last paragraph and Col 5 first paragraph of Truckai).
Response to Arguments
Applicant’s arguments with respect to the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The new limitations are addressed as rejected as above with the art of record.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Lawrence (US-20040087932-A1) and Holden (US-5957910-A).
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARTIN A RADOMSKI/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
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