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
This office action is responsive to the amendment filed on 23 January 2026. As directed by the amendment: claims 1-2, 5-8, 10-14, 16, and 20 have been amended, claims 3 and 9 have been or remain canceled. Thus claims 1-2,4-8,10-18 and 20 are presently pending in this application, and claims 5-7 and 19 are withdrawn. Applicant’s amendments to the Claims have overcome each objection and 35 U.S.C. 112(b) rejection previously set forth in the Non-Final Office Action mailed 18 November 2025.
Response to Arguments
Applicant's arguments filed 23 January 2026 have been fully considered but they are not persuasive.
Applicant argues Panescu teaches only three different angiograms. The examiner respectfully disagrees. The catheter marker includes the first marker 1746 which is the “N” shape and the second marker which is the lines 1748 which is parallel lines shown in Fig 21. The combination of 1746 and 1748 results in at least 4 possible angiograms that would be formed: the backwards N between the lines shown in Fig 21, the N between the lines in Fig 22, the N aligned with one of the lines in Fig 23, the N seen from the side forming a line as shown in Fig 20, in addition to others, such as a backwards N aligned with one of the lines, the N being narrowed, a backwards and narrowed N… There are countless shapes that could be imaged depending on the degree of rotation of the catheter, every incremental change would make the markers appear slightly different, there are more possible angles than just the examples shown in Figs 21-23. Additionally, the angiograms formed can be taken from many orientations relative to the catheter, for example, viewing the catheter head on would result in a different shape.
Applicant argues Hiroshige does not disclose or suggest the catheter marker is configured to form at least four angiograms as claimed. The examiner respectfully disagrees. Different shapes will be formed in an X-ray depending on how the catheter is bent and the direction of the X-rays. The examiner has depicted four possible angiograms in the annotated Fig in the rejection of claim 8 below, in view of Pedersen et al. While Hiroshige does teach the catheter marker configured to form different shapes, the claim amendments have overcome the rejection in view of Hiroshige and a new ground of rejection is made in view of Pedersen as outlined further below.
Claim Objections
Claim 20 is objected to because of the following informalities:
Claim 20 recites “a reinforcement body”, however, this was introduced in claim 8 so should instead recite “the reinforcement body”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 18 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 18 depends upon claim 9 which was canceled, for the purpose of examination, it is being interpreted as depending upon claim 8. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
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 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 1-2 and 4 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Panescu et al. (US 2021/0128229 A1).
Regarding claim 1, Panescu et al. discloses a catheter (102 Fig 1, with the markers shown in Fig 21, [0258] “The device 100 of FIGS. 1 to 5 may include one or more radiopaque markers”), comprising: a hollow shaft ([0244] “the catheter 102 includes a guidewire lumen (not shown) extending therethrough (along the catheter axis 104)”) including a distal end (108 in Fig 1, equivalent to the end shown in Fig 21) and a proximal end (106 in Fig 1), a hand-side unit provided to the proximal end of the shaft (see the handheld unit attached to the proximal end in Fig 1), and a catheter marker (1746 and 1748 Fig 21) having a radiopaque property ([0260] “radiopaque marker”); the catheter marker includes a first marker (1746 Fig 21) and a second marker (1748 Fig 21); the first marker and the second marker have different shapes (the first marker has an “N” shape, the second marker is two lines) and are arranged to the shaft by being spaced apart from each other ([0260] “Particularly, the additional radiopaque marker 1748 includes two lines the center of which is circumferentially spaced from the radiopaque marker 1746 by about 180 degrees”); wherein the catheter marker has a left-right asymmetrical shape with respect to a symmetrical plane of the shaft (the marker 1746 of the catheter marker has left-right asymmetry: [0259] “the radiopaque marker 1746 is made from a radiopaque material and is asymmetric in shape.”); and wherein the catheter marker is configured to form at least four angiograms having different shapes depending on an incident direction of X-rays (the first marker 1746 and the second marker are configured to form at least the backwards N between the lines shown in Fig 21, the N between the lines in Fig 22, the N aligned with one of the lines in Fig 23, the N seen from the side forming a line as shown in Fig 20).
Regarding claim 2, Panescu et al. discloses the catheter according to claim 1. Panescu et al. further discloses wherein the catheter marker includes at least one among a welding point of metal wires, an overlapping portion of metal wires that forms a reinforcement body, and a catheter opening portion that contains a radiopaque agent (the distal end shown in Fig 21 is an opening portion because it includes the oval side opening, the distal end includes the radiopaque markers).
Regarding claim 4, Panescu et al. discloses the catheter according to claim 1. Panescu et al. further discloses wherein at least one of the first marker and the second marker has a left-right asymmetrical shape with respect to the symmetrical plane of the shaft (the N shaped marker 1746 has left-right asymmetry).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 8, 10, 12-16, 18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Pedersen et al. (US 2001/0003297 A1) in view of Gunderson et al. (US 2008/0125752 A1).
Regarding claim 8, Pedersen et al. discloses a catheter (40 Fig 9), comprising: a hollow elongated shaft (see the hollow shaft of 40 in Fig 9) including a distal end (the left side of 40 Fig 9) and a proximal end (it is not shown but the right side of 40 Fig 9 would necessarily extend to a proximal end), the hollow elongated shaft including an outer layer (16 Fig 9), an inner layer (12 Fig 9), and a braid (14b Fig 9), the braid being arranged between the outer layer and the inner layer and formed from a plurality of metal wires ([0034] “formed in a braided pattern on the first layer 12”, [0035] “one or more second metal wires 14b made of a second material formed in a second pattern” the embodiment relied upon is where there is more than one wire, as shown in Fig 5), which are woven together forming a reinforcement body (the braid of wires 14b is a reinforcement body); a catheter marker having a radiopaque property ([0034] “radiopaque elements 14a may overlap second radiopaque elements 14b”), the catheter marker including a first marker ([0011] “The one or more elongated filaments may be coiled.”, the embodiment relied upon is where there is only one filament of 14a coiled) and a second marker (braid from wires 14b Fig 9) each having a different shape (14b is braided, 14a is coiled), and the first marker and the second marker being spaced apart from each other ([0009] “separated radially apart from one another by a space or a material.”), a radiopaque metal wire ([0034] “radiopaque elements 14a”), which is a different metal wire than the plurality of metal wires of the braid ([0035] “one or more wires 14a made of a first metal material formed in a first pattern, and one or more second metal wires 14b made of a second material formed in a second pattern”), is coil-wound around an outer side of the braid to form a coil marker ([0011] “The one or more elongated filaments may be coiled.”, [0034] “radiopaque elements 14a may overlap second radiopaque elements 14b”), which serves as the first marker, and wherein the braid is cut out (while not described as being cut, the wires 14a forming the braid end as shown in Fig 5, this is an equivalent structure to braided wires that have been cut); wherein the catheter marker is configured to form at least four angiograms having different shapes depending on an incident direction of X-rays (the catheter is described as having flexibility for use in a body lumen [0008], because the catheter can bend it is configured to form countless shapes depending on an incident direction of X-rays, see the examiners depiction of four angiograms depicting the catheter bent at the end in the Examiner’s Fig 1 below); and wherein the catheter marker has a left-right asymmetrical shape with respect to a symmetrical plane of the hollow elongated shaft ([0011] “The one or more elongated filaments may be coiled.”, when there is only one wire 14a forming a coil, there would be left-right asymmetry as the coiled wire would only be wound in one direction).
However, Pedersen et al. fails to teach a welding portion generated when an intersection of the braid is welded is used as the second marker.
Gunderson et al. teaches a welding portion generated when an intersection of the braid is welded ([0025] “weld 26 joins together intersecting or adjoining wire filaments that form braid 22”) is used as the second marker ([0026] “weld 26 may be more easily visualized using fluoroscopic imaging than a plurality of loose wire ends”). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the catheter of Pedersen et al. to include the limitations as taught by Gunderson et al. to “prevent the ends of the wires making up braid 22 from fraying, losing and/or changing position, protruding, etc. In addition, weld 26 may be more easily visualized using fluoroscopic imaging than a plurality of loose wire ends.” [0026]
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Regarding claim 10, modified Pedersen et al. teaches the catheter according to claim 8. Pedersen et al. further teaches wherein the first marker (coil of 14a) is made of gold ([0011] “The filaments may include […] gold”).
Regarding claim 12, modified Pedersen et al. teaches the catheter according to claim 10. Pedersen et al. further teaches wherein the plurality of wires of the braid have a diameter of 25.4 μm to 127 μm ([0025] “The elements 14a, 14b may have an average diameter between about 0.001 inches and about 0.005 inches”, 0.001 inch is 25.4 μm, 0.005 inch is 127 μm).
However, Pedersen et al. does not explicitly teach the plurality of wires of the braid have a diameter of 5 μm to 100 μm.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the diameter of Pedersen et al. from between 25.4 μm to 127 μm to between 5 μm to 100 μm as applicant appears to have placed no criticality on the claimed range (see pp. [0027] indicating “the thickness of the wires of the braid 4 is not specifically limited”) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 13, modified Pedersen et al. teaches the catheter according to claim 12. Pedersen et al. further teaches wherein the plurality of wires of the braid have a cross-section that is circular, elliptical, rectangular, or oval (See the circular cross section of 14b Fig 6).
Regarding claim 14, modified Pedersen et al. teaches the catheter according to claim 10. Pedersen et al. further teaches wherein the coil marker (14a ) includes a distal side cut plane (The end of the wire 14a at the distal end of the catheter forms a cut plane) and a proximal side cut plane (The end of the wire 14a overlapping 14b as shown in Fig 5 forms a cut plane), and a shape of the coil marker is left-right asymmetrical with respect to a symmetrical plane to which a surface shape of the hollow elongated shaft is left-right symmetrical ([0011] “The one or more elongated filaments may be coiled.”, when there is only one wire 14a forming the coil, there would be left-right asymmetry as the coiled wire would only be wound in one direction).
Regarding claim 15, modified Pedersen et al. teaches the catheter according to claim 14. Modified Pedersen et al. further teaches wherein a distance from a distal end of the welding portion of the braid to a distal end of the distal side cut plane exceeds 0 mm and equal to or less than 1 mm ([0023] “The first tube 20 may have a length of from about 0.1 cm” 0.1 cm is 1 mm, when the length of the distal end section is 1 mm, where it includes the overlapping portion, the distance from the distal end of the braid where it is modified to be welded to the distal end of the coil would be greater than 0 mm and less than 1 mm.).
Regarding claim 16, modified Pedersen et al. teaches the catheter according to claim 8. Pedersen et al. further discloses wherein the coil of the first marker is a coil wire ([0005] “The elongated elements may be made of at least one of a wire, filament or ribbon”, [0011] “The one or more elongated filaments may be coiled.”), the coil wire having a cross-sectional shape that is circular, elliptical, rectangular, or oval (See the circular cross-sectional shape of 14a in Fig 6).
Regarding claim 18, modified Pedersen et al. discloses the catheter according to claim 8 (see the rejection of claim 18 under 112(d) as outlined above). However, modified Pedersen et al. does not explicitly disclose how many windings the coil comprises.
There is no evidence of record that establishes that changing the number of windings would result in a difference in function of the Pedersen et al. device. Further, a person having ordinary skill in the art, being faced with modifying the device, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed windings. Lastly, applicant has not disclosed that the claimed number of windings solves any stated problem, indicating that the coil is “preferably” equal to or less than 10, and offering other acceptable ranges ([0051] “equal to or less than 5 winding”) and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the coil of Pedersen et al. to comprise 10 or less windings as an obvious matter of design choice within the skill of the art.
Regarding claim 20, modified Pedersen et al. discloses the catheter according to claim 8. Pedersen et al. further discloses wherein the catheter marker includes an overlapping portion of metal wires that forms a reinforcement body (The braid of 14b Fig 9), and a catheter opening portion that contains a radiopaque agent (The distal end of the catheter having the opening shown in Fig 9 includes the radiopaque agent of the wires 14a).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Pedersen et al. (US 2001/0003297 A1) in view of Gunderson et al. (US 2008/0125752 A1) and Hiroshige et al. (US 20140214006 A1).
Regarding claim 11, modified Pedersen et al. teaches the catheter according to claim 10. However modified Pedersen et al. fails to teach wherein the plurality of wires of the braid are tungsten or stainless steel.
Hiroshige et al. teaches the plurality of wires of the braid are tungsten or stainless steel ([0003] “the braid is generally formed by weaving wires made of a metal, such as tungsten or stainless steel”). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the plurality of wires of the braid to have the limitations as taught by Hiroshige et al. to “achieve the performances (pushing performance, torque transmission performance, pressure resistance, etc.) required of the catheter” [0003].
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Pedersen et al. (US 2001/0003297 A1) in view of Gunderson et al. (US 2008/0125752 A1) and Itou et al. (US 20060229589 A1).
Regarding claim 17, modified Pedersen et al. teaches the catheter according to claim 16. Pedersen et al. further teaches the coil wire (14a) having a width of 25.4 μm to 127 μm ([0025] “The elongated elements may have an average diameter or thickness between about 0.001 inches and about 0.005 inches.”, 0.001 inch is 25.4 μm, 0.005 inch is 127 μm).
However, modified Pedersen et al. fails to teach wherein the cross-sectional shape of the coil wire is rectangular, and does not explicitly teach the coil wire having a width of 10 μm to 500 μm.
Itou et al. teaches a cross-sectional shape of reinforcement wires of a catheter is rectangular and having a width of 10 μm to 500 μm (See the rectangular cross section in Fig 3, [0068] “flat plate-like reinforcing wires (16 wires in a set) of 126 μm width”). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the coil wire of modified Pedersen et al. to have a shape and width as taught by Itou et al. so the wires have a ratio that provides adequate kink resistance [0054] and “so that the wall thickness of the catheter main body 3 can be relatively thin in the radial direction” [0035].
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.
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/A.E.V./Examiner, Art Unit 3783
/COURTNEY FREDRICKSON/Primary Examiner, Art Unit 3783
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