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 .
Information Disclosure Statement
The information disclosure statement filed 10/20/2025 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because the English translation provided for NPL cite no. 3 (“Chinese Office Action received for CN Application No.: 202080094268.X, mailed 28 March 2024, 23 pages”) is not legible due to the small and blurry text. The IDS has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 4-6, 13-15 and 191 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ogle (US Pat 10,478,535).
Re claim 1, Ogle discloses a guiding device 230 (Fig 6-10; it is noted that all reference characters cited below refer to Fig 6-10 unless otherwise noted) for a vascular catheter that is inserted over a guidewire (the italicized text constitutes functional language and, therefore, neither “a vascular catheter” nor “a guidewire” are part of the claimed “guiding device”; this limitation is met in view of Col 9, Lines 4-16), the guiding device comprising: a tapered component 234+236 for passing through a bore of the vascular catheter and extending from a distal end thereof (as set forth above, the “vascular catheter” is not a part of the claimed invention; this limitation is met in view of Fig 1 wherein “suction extension 230” is equivalent to “suction extension 104”), the tapered component having an aperture (as seen in Fig 8,10) through which the guidewire may pass so that the tapered component may move along the guidewire (as set forth above, the “guidewire” is not a part of the claimed invention; this limitation is met in view of Col 9, Lines 4-16); and pushing means 232 extending from the tapered component (as seen in Fig 6-8) and configured to extend beyond a proximal end of the vascular catheter (as set forth above, the “vascular catheter” is not a part of the claimed invention; this limitation is met in view of Fig 1 wherein “suction extension 230” is equivalent to “suction extension 104”); wherein the tapered component comprises a first section (labeled in annotated Fig A below as the portion having a consistent outer diameter “OD” in Fig 9), a second section (labeled in Fig A below as the portion extending between the portion having a consistent OD in Fig 9 and portion 246) and a third section 246; the first section is disposed between a proximal end of the tapered component and the second section (as seen in Fig A below); the second section is disposed between the first section and the third section (as seen in Fig A below); and the third section is disposed between the second section and a distal end of the tapered component (as seen in Fig A); wherein the first section is a cylinder (as evidenced by a constant outer diameter “OD” in Fig 9), the second and the third sections are conical (as evidenced by a change in thickness of tubing 260 and a change in thickness of tubing 240, as seen in Fig 9,10), and a taper of the second section differs from a taper of the third section (as seen in Fig A below).
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Re claim 4, Ogle discloses that the proximal end of the first section coincides with the proximal end of the tapered component (as seen in Fig 8).
Re claim 5, Ogle discloses that the distal end of the third section coincides with the distal end of the tapered component (as seen in Fig 8).
Re claim 6, Ogle discloses that movement of the tapered component along the guidewire is controllable proximally from beyond the proximal end of the vascular catheter by movement of the pushing means (Col 13, Lines 23-28).
Re claim 13, Ogle discloses that the pushing means has a non-circular cross-section (Col 14, Lines 35-37).
Re claim 14, Ogle discloses that the cross-section of the pushing means has a plurality of sides (inherent in a “flat wire”, Col 14, Lines 35-37).
Re claim 15, Ogle discloses that adjacent sides of the plurality of sides are of different lengths (a “flat wire” inherently has opposite sides that are longer than the sides that join them, Col 14, Lines 35-37).
Re claim 19, Ogle discloses that the tapered component comprises an internal bore (seen in Fig 8-10) accessible through the aperture of the tapered component (as seen in Fig 8-10).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 2 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Ogle (US Pat 10,478,535) in view of Nakajima (PG PUB 2008/0039796).
Re claims 2 and 3, Ogle discloses all the claimed features except that the second section is a convex conic section (as required by claim 2) and the third section is a concave conic section (as required by claim 3). Nakajima, however, teaches providing a guiding device 41 (Fig 5) with a first cylindrical section 43 (Fig 5), a second convex conic section 45 (Fig 5; Para 53, “smooth convex cone shape”), and a third concave conic section (the section of portion 42 distal to tapered portion 45, Fig 5; Para 53, “smooth ‘concave’ cone shape”) for the purpose of reducing the insertion resistance of the guiding device (Para 53). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Ogle to include the second section as a convex conic section and to include the third section as a concave conic section, as taught by Nakajima, for the purpose of reducing the insertion resistance of the guiding device (Para 53).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Ogle (US Pat 10,478,535) in view of Root et al. (US Pat 8,048,032).
Re claim 7, Ogle discloses all the claimed features except a connector, connectable to the pushing means, for releasably connecting the guiding device to the proximal end of the vascular catheter. Root, however, teaches a substantially similar guiding device 14 (Fig 1) comprising a tapered component 46+48 (Fig 1), a pushing means 44 (not labeled in Fig 1 but extending between clip 54 and straight portion 48; described in Col 6, Lines 55-56,62-63), and a connector 54 (Fig 1), connectable to the pushing means, for releasably connecting the guiding device to a proximal end of a vascular catheter 12 (as seen in Fig 2; Col 6, Lines 64-67) for the purpose of ensuring that the guiding device remains within the vascular catheter to provide it with enough inner support for proper translation over a guidewire (Page 7, Lines 53-57). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Ogle to include a connector, as taught by Root, for the purpose of ensuring that the guiding device remains within the vascular catheter to provide it with enough inner support for proper translation over a guidewire (Page 7, Lines 53-57).
Claims 8-12 are rejected under 35 U.S.C. 103 as being unpatentable over Ogle (US Pat 10,478,535)/Root et al. (US Pat 8,048,032) in view of Fujita et al. (US Pat 6,245,029).
Re claims 8-11, Ogle as modified by Root in the rejection of claim 7 above discloses all the claimed features except that the connector comprises a free-wheeling mechanism configured to permit a connection of the connector to the proximal end of the vascular catheter without causing rotation of the pushing means (as required by claim 8), wherein the connector comprises a body connectable to the pushing means and the free-wheeling mechanism comprises a free-wheeling ring for connecting to the vascular catheter (as required by claim 9), wherein the free-wheeling ring is axially restrained relative to the body of the connector and may rotate freely about the body of the connector (as required by claim 10) and a rim to restrain the free-wheeling ring in a distal direction relative to the body of the connector (as required by claim 11). Fujita, however, teaches a guiding device (seen in Fig 1) comprising a pushing means 1 (Fig 1,3,4) and connector 2 (Fig 1,3,4) for releasably connecting the guiding device to a proximal end of a catheter (as seen in Fig 6), wherein the connector comprises a free-wheeling mechanism 23 (Fig 3,4) in the form of a free-wheeling ring (as seen in Fig 4) that is configured to permit the connection of the connector to the proximal end of the vascular catheter without causing rotation the pushing means (Col 2, Lines 43-46) and a body 20 (Fig 3,4) connectable to the pushing means, wherein the free-wheeling ring is axially restrained in the distal direction relative to the body via a rim (labeled in annotated Fig B below; Col 3, Lines 37-43) and may rotate freely about the body of the connector (Col 2, Lines 43-46); Fujita teaches that such a connector allows the guiding device to be attached to catheters having double-start threads or male screw threads (Col 3, Lines 43-46). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Ogle/Root to include the connector as one comprising a body with a rim and a free-wheeling ring, as taught by Fujita, for the purpose of allowing the guiding device to be used with catheters having threaded connectors (Col 3, Lines 43-46). This modification would result in clip 54 of Root being replaced by assembly 2 of Fujita.
Re claim 12, Ogle/Root discloses all the claimed features except that the connector is moveable along the pushing means. Fujita, however, teaches a guiding device (seen in Fig 1) comprising a pushing means 1+20 (Fig 1,3,4) and a connector 23 (Fig 1,3,4) that is moveable along the pushing means (Col 3, Lines 37-43); Fujita teaches that such a connector allows the guiding device to be attached to catheters having double-start threads or male screw threads (Col 3, Lines 43-46). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Ogle/Root to include the connector as one that is moveable along the pushing means, as taught by Fujita, for the purpose of allowing the guiding device to be used with catheters having threaded connectors (Col 3, Lines 43-46). This modification would result in clip 54 of Root being replaced by assembly 2 of Fujita.
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Claims 18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Ogle (US Pat 10,478,535) in view of Chou et al. (PG PUB 2018/0361114).
Re claim 18, Ogle discloses that the pushing means can have “any reasonable cross sectional shape” (Col 13, Lines 28-29), but does not explicitly disclose that the plurality of sides comprises a first curved side that conforms with part of a circumference of an outer surface of the proximal end of the tapered component. Chou, however, teaches a guiding device 200 (Fig 3) comprising a distal component (the portion of 222 distal to trough 238, as seen in Fig 5A,5B; comparable to the tapered component of Ogle) and a pushing means 238+230 (Fig 5A-5F), wherein the pushing means has a non-circular cross-section (as seen in Fig 5A-5F) with a plurality of sides comprising a first curved side (facing upward in Fig 5A) conforming with a part of a circumference of an outer surface of the proximal end of the distal component (as seen in Fig 5A-5F; Para 131) for the purpose of reducing the likelihood of the pushing means kinking and facilitating pushing the distal component against resistance (Para 131). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Ogle to include the pushing means with a cross-section having a first curved side that conforms with part of the circumference of the outer surface of the tapered component, as taught by Chou, for the purpose of reducing the likelihood of the pushing means kinking and facilitating pushing the tapered component against resistance (Para 131).
Re claim 20, Ogle discloses that a cross-section of the pushing means has a plurality of sides (inherent in a “flat wire”, Col 14, Lines 35-37), but does not explicitly disclose that the plurality of sides comprises a first curved side and a second curved side, wherein the second curved side conforms with a part of a circumference of the internal bore of the tapered component. Chou, however, teaches a guiding device 200 (Fig 3) comprising a distal component (the portion of 222 distal to trough 238, as seen in Fig 5A,5B; comparable to the tapered component of Ogle) and a pushing means 238+230 (Fig 5A-5F), wherein the pushing means has a non-circular cross-section (as seen in Fig 5A-5F) with a plurality of sides comprising a first curved side (facing upward in Fig 5A) and a second curved side (facing downward in Fig 5A) conforming with a part of a circumference of an internal bore of the tapered component (as seen in Fig 5A-5F; Para 131) for the purpose of reducing the likelihood of the pushing means kinking and facilitating pushing the distal component against resistance (Para 131). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Ogle to include the pushing means with a cross-section having a first curved side and a second curved surface that conforms with a part of the circumference of the internal bore of the tapered component, as taught by Chou, for the purpose of reducing the likelihood of the pushing means kinking and facilitating pushing the tapered component against resistance (Para 131).
Response to Arguments
Applicant's arguments filed 10/20/2025 have been fully considered but they are not persuasive.
Applicant argues that Ogle does not disclose that “the first section is a cylinder” and “a taper of the second section differs from a taper of the third section”.
Applicant agrees that the Examiner’s interpretation of the portion indicated as the “first section” in annotated Fig A above having a constant outer diameter “can be followed”, but disagrees that it is a “cylinder” in view of Col 6, Lines 57-62. The Examiner respectfully disagrees. Col 6, Lines 41-47 incorporate 14/949,574 by reference and Col 14, Lines 64-66 incorporate “a corresponding circular embodiment as shown in Figs. 21 and 22 of the ‘574 application”. As seen in Fig 21 of that Application (and included below), the proximal portion 530 of the guiding device 522 (corresponding to the “first section” indicated in annotated Fig A above) is a cylinder with ridges 534,536 formed thereon. Therefore, this argument is not persuasive.
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Applicant agrees that the Examiner’s interpretation of the portion of the “second section” seen in Fig 9 as being conical “can be followed”, but asserts (1) that there is no indication that the portion of the “second section” seen in Fig 10 is conical, (2) that there is no disclosure in Ogle suggesting that the portion of the “second section” seen in Fig 9 is continuous with the portion of the “second section” seen in Fig 10 and that Fig 6 shows that the two portions shown in Figs 9 and 10 are “separate sections of tubing”, (3) that Col 14, Line 66 – Col 15, Line 4 set forth that the adjacent section of the tubular extension has a distinct form to the connecting section, and (4) that Ogle suggests that the “second section” have stepped down diameters. These arguments are not persuasive. Fig A does not indicate that the fragmentary sectional views of the tapered component seen in Fig 9 and 10 are adjacent each other; rather, Fig 9 and Fig 10 are fragmentary sectional views of the tapered component of Fig 6 taken along the lines 9-9 and 10-10 of Fig 6 and Fig A indicates that the “second section” includes the entire portion of the tapered component that extends between these fragmentary sectional views. Additionally, the claims do not require the entire portion of the “second section” to be conical or tapered; rather, as written, the limitation “the second and third sections are conical, and a taper of the second section differs from a taper of the third section” only requires at least a portion of the “second section” to be conical and only requires at least a portion of the “second section” to have a taper. So even if the portion of the “second section” shown in Fig 10 and/or the portion of the “second section” that extends between the fragmentary section views is not tapered or conical, any part of the “second section” labeled in Fig A is stepped, the proximal portion of the “second section” seen in Fig 9 is still conical and has a taper.
Applicant argues that the taper at the proximal end of the “second section” is not disclosed as differing from the taper of the “third section”. The Examiner respectfully disagrees because the taper of the “third section” is clearly seen in Fig 10 as being steeper than that of the “second section”. Therefore, this argument is not persuasive.
Applicant asserts that “Ogle would not provide one of ordinary skilled in the art with any reasoned basis to modify its device to be configured as claimed”, that “the shape of the tapered component as defined by claim 1 eases passage of the vascular catheter through an artery, reducing the risk of the ‘razor effect’”, that “Ogle does not recognize or address this issue” and that “one skilled in the art looking to Ogle for solutions to prevent the ‘razor effect’, without having knowledge of the present application, would find no suggestion leading to making the taper of the second section differ from the taper of the third section”. This argument is moot because, as set forth immediately above, Ogle does not disclose that the tapers of the second and third sections differ.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAMI A BOSWORTH whose telephone number is (571)270-5414. The examiner can normally be reached Monday - Thursday 8 am - 4 pm.
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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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/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
1 It is noted that, due to the 112(b) rejection of claim 19 in the last Office Action, claim 19 was interpreted as depending on claim 18; this resulted in claim 19 being rejected with claim 18 under 35 USC 103. However, the amendments filed 10/20/2025 overcome the 112(b) rejection in such a way that the previously-applied interpretation no longer applies and claim 19 requires dependence on claim 1. Therefore, this change in rejection is based on the amendments filed 10/20/2025.