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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 7/28/2026 has been entered.
Response to Amendment
The amendment filed 7/28/2026 has been entered. Claims 1-5 and 7-21 are pending in the application. Applicant’s amendments to the Claims have overcome each and every objection previously set forth in the Final Office Action mailed 5/29/2026.
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, 13-15, and 21 is/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 distal section of sheath 18 may be interpreted as the distal tip section, which comprises a distal portion of wire braid 34, which is being interpreted as a tip braid, Fig. 1B; the distal tip section is being interpreted as the section distal to the “Transition Point” annotated below in Fig. 3); 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), a distal portion (distal loop 33 defining the distal portion of wires 32, [0046] & Fig. 3), and a transition point located between the proximal portion and the distal portion, the transition point being proximal of the distal tip section (the point at which axial wire 32 transitions into the distal loop 33 is being interpreted as a transition point, see “Transition Point” annotated in Fig. 3 below; the “Transition Point” is seen located between the proximal portion of wires 32 and the distal loop 33 and proximal to the distal end of braid 34, see Fig. 1B and annotated Fig. 3 below, with the proximal portion annotated as “Proximal Portion” and the distal portion annotated as “Distal Portion”; Figs. 1B and 3-4 illustrate the wire braid 34 extending along the full length of sheath 18), 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, [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).
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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 distal section of sheath 18 may be interpreted as the distal tip section, which comprises a distal portion of wire braid 34, which is being interpreted as a tip braid, Fig. 1B; the distal tip section is being interpreted as the section distal to the “Transition Point” annotated above in Fig. 3); 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), a distal portion (distal loop 33 defining the distal portion of wires 32, [0046] & Fig. 3), and a transition point located between the proximal portion and the distal portion, the transition point being proximal of the distal tip section (the point at which axial wire 32 transitions into the distal loop 33 is being interpreted as a transition point, see “Transition Point” annotated in Fig. 3 above; the “Transition Point” is seen located between the proximal portion of wires 32 and the distal loop 33 and proximal to the distal end of braid 34, see Fig. 1B and annotated Fig. 3 above, with the proximal portion annotated as “Proximal Portion” and the distal portion annotated as “Distal Portion”; Figs. 1B and 3-4 illustrate the wire braid 34 extending along the full length of sheath 18), 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, [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).
Regarding claim 21, Salahieh, as modified, discloses all the limitations of claim 1. Salahieh, as modified, further discloses the catheter wherein the spine hoop wraps around the one or more of the distal hoops of the tip braid (as modified, loop 33 of axial wire 32 of Salahieh would wrap around one or more distal hoops formed by wire braid 34 in the distal tip section, see Fig. 1B and 3 of Salahieh; loop 33 would surround, or wrap, around at least one of the one or more distal hoops considering loop 33 is disclosed as provided at a distal end of wires 32, [0061], and seen extending to the distal end of sheath 18, see [0046] and [0061] & Fig. 3 and 49; the distal hoops are provided throughout the distal tip section comprising the distal portion of wire braid 34).
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 filed 7/28/2026 have been fully considered but they are not persuasive.
In response to Applicant’s arguments that “Salahieh does not teach, disclose, or suggest that a transition point between the proximal and distal portions of the axial wire should be proximal of the distal tip.”, the Examiner finds that the transition point, annotated in Fig. 3 above, is positioned between loop 33 and the proximal portion of wires 32 and is proximal to the distal end of wire braid 34.
In response to Applicant’s arguments that “Fig. 3 shows that the two strands of the axial wire are separated at the distal end of the catheter forming the atraumatic tip, not at a location that is proximal of the distal end.”, the Examiner finds that the transition point is positioned proximal to the distal end of sheath 18. Figures 1B and 3-4 illustrate the wire braid 34 extending along the full length of sheath 18.
In response to Applicant’s arguments that “Neumann arguably teaches away from having the same number of filaments at the distal most end of the braid, as one of ordinary skill in the art could reasonably expect that there would not be the required increase in radial flexibility of the distal end without having a decrease in the number of filaments.”, the Examiner finds that axial wires 32 provide axial compliance ([0061]) and wire braid 34 provides radial compliance ([0045]-[0046]). The wire braid density and thickness can be varied to achieve a desired level of radial compliance. The axial stiffness can be varied by providing more or less axial wires 32 or by making the wires non continuous ([0046]). Therefore, the sheath can include the number of filaments at the distal most end of the braid, forming the distal hoops, being offset and decreasing in a distal direction along with an axial wire 32 forming a loop 33 as the two structures serve different functions. Salahieh explicitly discloses varying characteristics of the distal end of the braid and the axial wire to achieve desired radial and axial compliance ([0046]).
Conclusion
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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