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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 4/28/2026 has been entered.
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 1,3-6, 13-15, 19 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nita (US Pat 8,246,643).
Re claim 1, Nita discloses a guiding device 60K+66K (Fig 19; it is noted that all reference characters cited below refer to Fig 19 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 Fig 19 that shows a guidewire 25K within the guiding device and one of ordinary skill in the art would recognize that a catheter having an inner diameter greater than the outer diameters of the proximal portion 142 and catheter body 11K could be received thereover), the guiding device comprising: a tapered component 66K 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 since one of ordinary skill in the art would recognize that the tapered component 66K would be capable of passing through and extending from a catheter having an inner diameter greater than the outer diameters of the proximal portion 142 and catheter 11K), the tapered component having an aperture (as seen in Fig 19, at the distal end (labeled in Fig A below) and within which the distal end of the pushing means 60K resides) 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 Fig 19 which shows guidewire 25K passing through the aperture); and pushing means 60K extending from the tapered component (as seen in Fig 19, extending proximally from the tapered component 66K) 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 since one of ordinary skill in the art would recognize that the guiding device 60K+66K could be used with a vascular catheter that is shorter in length than the guiding device) wherein the tapered component comprises a first section (labeled in annotated Fig A below), a second section (labeled in Fig A below) and a third section (labeled in annotated Fig A below); the first section is disposed between a proximal end (labeled in annotated Fig A below) of the tapered component and the second section (as seen in Fig A below; the “proximal end” is a proximal end of the first section of the tapered component; it is noted that the claim does not require the “proximal end” to be the proximal-most end of the tapered component as a whole); 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 (labeled in annotated Fig A below) of the tapered component (as seen in Fig A below; the “distal end” is a distal end of the third section of the tapered component; it is noted that the claim does not require the “distal end” to be the distal-most end of the tapered component as a whole); wherein the first section is a cylinder (as seen in Fig A below), the second and the third sections are conical (as seen in Fig A below), and a taper of the second section differs from a taper of the third section (as seen in Fig A below), and wherein the second section is a convex conic section (as seen in Fig A below).
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Re claim 3, Nita discloses that the third section is a concave conic section (as seen in Fig A above).
Re claim 4, Nita discloses that the proximal end of the first section coincides with the proximal end of the tapered component (as seen in Fig A above).
Re claim 5, Nita discloses that the distal end of the third section coincides with the distal end of the tapered component (as seen in Fig A above).
Re claim 6, Nita 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 (due to the pushing means being adhesively attached to the tapered component – Col 10, Lines 48-51).
Re claim 13, Nita discloses that the pushing means has a non-circular cross-section (Fig 19 shows a partial view of a cross-section of the pushing means; this figure shows a top side, a bottom side and a right side, but does not shown the left side; as seen in Fig 19, this specific cross-section is not circular since the top side and the bottom side run parallel to each other; it is noted that the claim does not specify in which plane the cross-section must be taken).
Re claim 14, Nita discloses that the cross-section of the pushing means has a plurality of sides (as seen in Fig 19, the cross-section of the pushing means has a top side, a right side and a bottom side; additionally, since the pushing means is not an infinite length, it also inherently includes a left side that is not shown).
Re claim 15, Nita discloses that adjacent sides of the plurality of sides are of different lengths (as seen in Fig 19, the top side is longer than the right side).
Re claim 19, Nita discloses that the tapered component comprises an internal bore (within which the pushing means resides in Fig 19), accessible through the aperture of the tapered component (as seen in Fig 19).
Re claim 20, Nita discloses that a cross-section of the pushing means (in a plane that extends into the page in Fig 19) has a plurality of sides that comprises a first curved side and a second curved side (as seen in Fig 11, the pushing means has a circular cross-section where the “first curved side” is the upper half side of 60K and the “second curved side” is the bottom half side of 60K), wherein the second curved side conforms with a part of a circumference of the internal bore of the tapered component (as seen in Fig 19).
Claims 1, 4-6, 13-15 and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stivland (PG PUB 2010/0030186).
Re claim 1, Stivland discloses a guiding device 60 (Fig 8; it is noted that all reference characters cited below refer to Fig 8 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 since Fig 8 shows that a vascular catheter 70 can be received over the guiding device 60 and one of ordinary skill in the art would recognize that a guidewire can extend through the “proximal tubular portion” and the “distal tubular portion 62” described in Para 30, due to them being “tubular” in shape), the guiding device comprising: a tapered component 62 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 8 that shows the tapered component 62 can be passed through a catheter 70), the tapered component having an aperture (at the “distal end” labeled in Fig C below; comparable to opening 40 of Fig 3) 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 since the “proximal tubular portion” and the “distal tubular portion 62” described in Para 30 are “tubular”); and pushing means (wire 68 + “a proximal tubular portion (not shown)” as described in Para 30) extending from the tapered component (as seen in Fig 8, extending proximally from the tapered component 62) 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 7 that shows that the pushing means can extend beyond the proximal end of a vascular catheter) wherein the tapered component comprises a first section (labeled in annotated Fig C below), a second section (labeled in Fig C below) and a third section (labeled in annotated Fig C below); the first section is disposed between a proximal end (labeled in annotated Fig C below) of the tapered component and the second section (as seen in Fig C below; the “proximal end” is a proximal end of the first section of the tapered component; it is noted that the claim does not require the “proximal end” to be the proximal-most end of the tapered component as a whole); the second section is disposed between the first section and the third section (as seen in Fig C below); and the third section is disposed between the second section and a distal end (labeled in annotated Fig C below) of the tapered component (as seen in Fig C below; the “distal end” is a distal end of the third section of the tapered component; it is noted that the claim does not require the “distal end” to be the distal-most end of the tapered component as a whole); wherein the first section is a cylinder (as seen in Fig C below), the second and the third sections are conical (as seen in Fig C below), and a taper of the second section differs from a taper of the third section (as seen in Fig C below), and wherein the second section is a convex conic section (as seen in Fig C below).
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Re claim 4, Stivland discloses that the proximal end of the first section coincides with the proximal end of the tapered component (as seen in Fig C above).
Re claim 5, Stivland discloses that the distal end of the third section coincides with the distal end of the tapered component (as seen in Fig C above).
Re claim 6, Stivland 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 (due to the pushing means being directly attached to the tapered component, as seen in Fig 8).
Re claim 13, Stivland discloses that the pushing means has a non-circular cross-section (“a ribbon-shaped wire” – Para 28).
Re claim 14, Stivland discloses that the cross-section of the pushing means has a plurality of sides (inherent in “ribbon-shaped wire” – Para 28).
Re claim 15, Stivland discloses that adjacent sides of the plurality of sides are of different lengths (inherent in “ribbon-shaped wire” – Para 28).
Re claim 19, Stivland discloses that the tapered component comprises an internal bore (as seen in Fig 8), accessible through the aperture of the tapered component (as seen in Fig 8).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Stivland (PG PUB 2010/0030186) in view of Root et al. (US Pat 8,048,032).
Re claim 7, Stivland 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 Stivland 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 Stivland (PG PUB 2010/0030186)/Root et al. (US Pat 8,048,032) in view of Fujita et al. (US Pat 6,245,029).
Re claims 8-11, Stivland 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 Stivland/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, Stivland/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 Stivland/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 Stivland (PG PUB 2010/0030186) in view of Chou et al. (PG PUB 2018/0361114).
Re claim 18, Stivland discloses that the pushing means can be “a ribbon-shaped wire” (Para 28) which inherently has multiple sides, 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 Stivland) 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 Stivland 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, Stivland discloses that a cross-section of the pushing means has a plurality of sides (inherent in a “ribbon-shaped wire”, Para 28), 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 Stivland 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 4/28/2026 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. Rather, the present rejections utilize Nita and Stivland as the primary reference.
Conclusion
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/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
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