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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 7/30/2026 has been entered.
Response to Amendments and Arguments/Remarks
Applicant’s amendments and arguments/remarks filed on 7/30/2026 have been considered but are moot in view of the new grounds of rejection presented herein. Specifically, the applicant has amended: independent claim 1 to recite that there are multiple tapered shoulder distal of the stepped shoulder; independent claim 18 to recite the outer diameter of the tube and the an outer diameter of the proximal section of the core deviate by less than 1%; and added dependent claim 21 which is dependent on claim 1 and recites limitations to recite the inner surface of the tube and an outer surface of the stepped shoulder are in contact over the entire length of the stepped shoulder and the outer diameter of the tube and the an outer diameter of the proximal section of the core deviate by less than 1%.
The updated rejections below address the newly amended limitations, specifically the examiner has provided additional references US 2009/0118675 A1 to Czyscon et al which discloses it is known to have multiple stepped/tapered shoulders distal to an initial stepped shoulder; and US 5,682,894 to Orr et al which discloses it is known to have the outer diameter of a tubular member disposed on the distal end of a core wire deviate from the outer diameter of the proximal section of the core wire by less than 1%.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-4, 6-14 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Voeller et al (US 2009/0036834 A1) in view of Czyscon et al (US 2009/0118675 A1).
Regarding claims 1-4, 6-14 and 17; Voeller discloses an intravascular device (figures 1 and 2), comprising:
a core (element 28) having a proximal section (section of core, element 28, proximal to first diameter reduction; see annotated figure below) and a distal section (section of core, element 28, distal to second diameter reduction; see annotated figure below), wherein the core includes (i) stepped shoulder (constant diameter section between first diameter reduction and second diameter reduction) at a transition from the proximal section to the distal section (located between proximal section and distal section) and (ii) one tapered shoulders distal of the stepped shoulder (wherein paragraph [0044] of Voeller discloses the diameter transition can be smoothly tapering, step-wise or both, and thus contemplates an embodiment having a tapered shoulder section distal to the stepped shoulder; paragraph [0044]; see annotated figures 1 and 2),
wherein the stepped shoulder comprises a constant outer diameter (constant diameter) that extends parallel to a longitudinal axis of the core (wherein constant diameter section outer surface is parallel to longitudinal axis, see annotated figures 1 and 2 above),
wherein the core forms a distally facing surface proximal of the stepped shoulder (surface of core element 28 at diameter transitions from proximal section to shoulder section; see annotated figure below); and
wherein the distally facing surface is perpendicular to the longitudinal axis of the core (wherein paragraph [0044] states that the diameter transitions may be tapering, step-wise, or both, then an embodiment where the transition from the proximal section to the shoulder section is step-wise, the face of the proximal section would be perpendicular to the longitudinal axis of the core; paragraph [0044]; see annotated figure 1 and 2)
a tube (element 30) coupled to the core (via element 32 and/or 36) at the stepped shoulder the distal section of the core passing into and being encompassed by the tube (wherein examiner notes that Voeller discloses a step-wise transition structure for core element 28 instead of tapered, see paragraph [0044], and in a step-wise diameter transitions [i.e. not tapered, such that the diameter transition zones would be a single dotted line in the annotated figure below], the at least one of the connection points 32 and 36 is located at the stepped shoulder), the distal section of the core passing into and being encompassed by the tube (see annotated figures 1 and 2 below).
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However, while Voeller does disclose one tapered shoulder distal to the stepped shoulder, it does not explicitly disclose that the core wire includes multiple tapered shoulders distal of the stepped shoulder.
Czyscon teaches a known guidewire device with a shapeable distal tip wherein the distal tip can include multiple tapered shoulder distal to a first shoulder in order to provide a desired flexibility profile to the distal tip (paragraphs [0018]-[0032]; figure 2).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Voeller to include multiple tapered shoulders distal of the stepped shoulder as taught by Czyscon in order to provide a desired flexibility to the distal tip of the guidewire.
Further regarding claim 2; Voeller discloses the outer diameter of the stepped shoulder and an inner diameter of the tube are substantially similar (see annotated figures 1 and 2 above; wherein the examiner notes that the is a very small gap between the outer diameter of core element 28 and inner diameter of tube element 30, thus making them substantially similar [absent any specific definition of substantially from the specification]).
Further regarding claim 3; Voeller discloses an outer diameter of the tube is substantially the same as an outer diameter of the proximal section of the core (see annotated figures 1 and 2 above; wherein the examiner notes that the outer diameter of proximal section of core element 28 and outer diameter of tube element 30 are nearly identical, thus making them substantially similar [absent any specific definition of substantially from the specification]).
Further regarding claim 4; Voeller discloses an outer diameter of the tube is greater than an outer diameter of the proximal section of the core (see enlarged and annotated figure 2 below).
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Further regarding claim 6; Voeller discloses the tube is formed from a super-elastic material (discloses tube, element 30, can be made of super-elastic material; paragraph [0047]).
Further regarding claim 7; Voeller discloses at least a portion of the distal section of the core is a flat ribbon (discloses distal end of core, element 28, can be thin rectangular ribbon; paragraph [0044]).
Further regarding claim 8; Voeller discloses the core is formed from stainless steel (discloses core, element 28, can be made of stainless steel; paragraph [0047]).
Further regarding claim 9; Voeller discloses a radiopaque element disposed at or near a distal end of the device (discloses radiopaque material on device at distal end; paragraph [0040]).
Regarding claims 10 and 11; the Voeller/Czyscon combination is descried in the rejection of claim 1 above; however, it does not explicitly disclose that the tube (element 30) in the embodiment used in the rejection of claim 1 includes a plurality of fenestrations (claims 10) wherein the plurality of fenestrations for a plurality of axially extending beams and a plurality of circumferentially extending rings (claims 11).
In an alternate embodiment, Voeller discloses the tube (element 46) at the end of the guidewire (element 43) includes a plurality of fenestrations (element 48) wherein the plurality of fenestrations form a plurality of axially extending beams (longitudinally extending parts of the tube) and a plurality of circumferentially extending rings (ring elements of the tube) (paragraph [0043]; figure 10).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the Voeller/Czyscon combination by substituting the tube (element 30) at the distal end of the guidewire in figures 1 or 2 of Voeller with the tube (element 46) at the distal end of the guidewire in figure 10 of Voeller as simple substitution of one known element for another to yield a predictable result (in this case, the guidewire having the core wire of the Voeller/Czyscon combination guidewire with the tube (element 46) of Voeller figure 10).
Regarding claim 12; the Voeller/Czyscon combination is described in the rejection of claim 1 above; but it does not explicitly disclose the stepped shoulder has a length of about 1 cm to about 20 cm as Voeller is silent to dimensions. Voeller does disclose the stepped shoulder has a length (by its existence in figure 1 and 2). It would have been obvious to one of ordinary skill in the art at the time of filing to modify the Voeller/Czyscon combination guidewire to have a stepped shoulder that has a length of about 1 cm to about 20 cm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and the device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the Voeller/Czyscon combination guidewire would not operate differently with the claimed length of the stepped shoulder portion being about 1 cm to about 20 cm and the guidewire would function appropriately having the claimed shoulder length. Further, it appears that the applicant places no criticality on the range claimed, simply indicating that the shoulder “can have” outer a length within the claimed range (see paragraphs [0012] and [0038] of the published specification of the instant application).
Further regarding claim 13; Voeller discloses the distally facing surface is perpendicular to a longitudinal axis of the core (wherein Voeller discloses embodiment with step-wise reductions in diameter, then the surface formed by the step would be perpendicular to the longitudinal axis of the core; paragraph [0044]).
Further regarding claim 14; Voeller discloses the tube abuts the distally facing surface (see annotated figures 1 and 2 above; wherein tube element 30 abuts the surface of diameter reduction locations between proximal and shoulder section of core element 28).
Further regarding claim 17; the Voeller/Czyscon combination is described in the rejection of claims 1 above; however, it does not explicitly disclose that the stepped shoulder has an outer diameter that is 30% to 90% of the outer diameter of the proximal section of the core.
Voeller does disclose a stepped shoulder which has a diameter smaller than the outer diameter of the proximal section of the core, but does not disclose any values for the outer diameter of the proximal section of the core or the diameter of the stepped shoulder portion (see figures 1 and 2). It would have been obvious to one of ordinary skill in the art at the time of filing to modify the Voeller/Czyscon combination guidewire to have a stepped shoulder that has an outer diameter that is 30% to 90% of the outer diameter of the proximal section of the core since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and the device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the Voeller/Czyscon combination guidewire would not operate differently with the claimed outer diameter of the stepped shoulder portion being 30% to 90% of the outer diameter of the proximal section of the core and the guidewire would function appropriately having the claimed diameter. Further, it appears that the applicant places no criticality on the range claimed, simply indicating that the diameter “can have” outer diameters within the claimed ranges (see paragraphs [0011] and [0045] of the published specification of the instant application).
Claims 5 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Voeller in view of Czyscon as applied to claim 1 above, and further in view of Davis et al (US 2020/0222672 A1).
Regarding claim 5, the Voeller/Czyscon combination is described in the rejection of claim 1 above; furthermore, Voeller discloses the medical device may have a lubricous coating.
However, Voeller is silent that the lubricous coating is a hydrophilic coating.
Davis teaches a similar guidewire wherein the guidewire can have a lubricous coating and that hydrophilic coatings are suitable lubricous coatings for guidewires (paragraph [0066]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to make Voeller’s lubricous coating be a hydrophilic coating as taught by Davis as it is a well-known coating for providing a lubricous surface to move the guidewire through the body.
Regarding claim 16; the Voeller/Czyscon combination is described in the rejection of claim 1 above; however, it does not disclose the guidewire further comprises one or more coils disposed between the core and the tube.
Davis teaches a similar guidewire wherein there are one or more coils (elements 212 and 214) disposed between the core (element 203) and the tube (element 204) in order to center the core inside the tube (paragraphs [0034]-[0043]; figures 3).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the Voeller/Czyscon combination guidewire to further include one or more coils disposed between the core and the tube as taught by Davis in order to help center the core within the tube.
Claims 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Voeller in view of Czyscon as applied to claim 1 above, and further in view of Uihlein (previous cited foreign patent document DE 44 45 879 A1, provided English machine translation relied upon for citations) and Orr et al (US 5,682,894).
Regarding claim 21; the Voeller/Czyscon combination is described in the rejection of claim 1 above. Voeller further discloses that the outer diameter of the tube is substantially the same as an outer diameter of the proximal section of the core (see annotated figures 1 and 2 from rejection of claim 1 above; wherein the examiner notes that the outer diameter of the proximal section of core element 28 and outer diameter of tube element 30 are nearly identical, thus making them substantially similar [absent any specific definition of substantially from the specification]).
However, the Voeller/Czyscon combination does not explicitly disclose wherein an inner surface of the tube and an outer surface of the stepped shoulder are in contact over the entire length of the stepped shoulder; or wherein an outer diameter of the tube and an outer diameter of the proximal section of the core deviate by less than 1%.
Uihlein teaches a similar guidewire having a stepped shoulder (element 4) on a core wire (element 1) wherein the guidewire includes an outer tubular element (coil spring, element 6) wherein an inner surface of the tubular member and an outer surface of the stepped shoulder are in contact over substantially the entire length of the stepped shoulder (page 3, paragraphs 4 and 5 of translation which describes diameter of d1 as being sized such that the proximal end of the tubular element 6 needs to be pushed onto shoulder element 4 to connect the tubular element to the core wire and help provide torqueability and pushability; see annotated figure 1 from Uihlein below).
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Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Voeller’s guidewire as described in the rejection of claim 1 and as described with regard to claim 18 above so that the inner surface of the tube and an outer surface of the stepped shoulder are in contact over the entire length of the stepped shoulder as taught by Uihlein in order to help ensure a strong connection between the tube and the core wire and improve torqueability and pushability.
The Voeller/Czyscon/Uihlein combination is described above; however, it does not explicitly state the outer diameter of the tube and an outer diameter of the proximal section of the core deviate by less than 1%.
Orr teaches a similar guidewire having a core wire with a proximal end (element 25) having a diameter and a distal section with a tubular element (combined coil elements 20 and 15) wherein the outer diameter of the tube and the outer diameter for the proximal section of the core wire deviate by less than 1% (wherein Orr teaches the outer diameter of the coil and the outer diameter of the proximal section of the core are exactly the same as the core wire proximal section has a 0.356 mm outer diameter and the outer diameter of the coil section is also 0.356 mm; column 3, lines 29-49; figure 1).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the Voeller/Czyscon/Uihlein combination such that the outer diameter of the tube and an outer diameter of the proximal section of the core deviate by less than 1% as taught by Orr as use of a known technique to improve similar devices in the same way (in this case applying Orr’s technique of a uniform outer diameter guidewire along the length of the guidewire to the Voeller/Czyscon/Uihlein combination
Claims 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Voeller as applied to claim 1 above, and further in view of Uihlein (previous cited foreign patent document DE 44 45 879 A1, provided English machine translation relied upon for citations) and Orr et al (US 5,682,894).
Regarding claims 18-20; Voeller discloses an intravascular device (figures 1 and 2), comprising:
a core (element 28) having a proximal section (section of core, element 28, proximal to first diameter reduction; see annotated figure from rejection of claim 1 above) and a distal section (section of core, element 28, distal to second diameter reduction; see annotated figure from rejection of claim 1 above), wherein the core includes (i) stepped shoulder (constant diameter section between first diameter reduction and second diameter reduction) at a transition from the proximal section to the distal section (located between proximal section and distal section) and (ii) one or more tapered shoulders distal of the stepped shoulder (at the transition area between the shoulder section and the distal section, wherein paragraph [0044] of Voeller discloses the diameter transition can be smoothly tapering, step-wise or both, and thus contemplates an embodiment having a tapered shoulder section distal to the stepped shoulder at the transition from the shoulder to the distal section; paragraph [0044]; see annotated figures 1 and 2 from rejection of claim 1 above),
wherein the stepped shoulder comprises a constant outer diameter (constant diameter) that extends parallel to a longitudinal axis of the core (wherein constant diameter section outer surface is parallel to longitudinal axis, see annotated figures 1 and 2 from rejection of claim 1 above),
wherein the core forms a distally facing surface proximal of the stepped shoulder (surface of core element 28 at diameter transitions from proximal section to shoulder section; see annotated figures from rejection of claim 1 above); and
wherein the distally facing surface is perpendicular to the longitudinal axis of the core (wherein paragraph [0044] states that the diameter transitions may be tapering, step-wise, or both, and when an embodiment where the transition from the proximal section to the shoulder section is step-wise, the face of the proximal section would be perpendicular to the longitudinal axis of the core; paragraph [0044]; see annotated figure 1 and 2 from rejection of claim 1 above)
a tube (element 30) coupled to the core (via element 32 and/or 36) at the stepped shoulder the distal section of the core passing into and being encompassed by the tube (wherein examiner notes that Voeller discloses a step-wise transition structure for core element 28 instead of tapered, see paragraph [0044], and in a step-wise diameter transitions [i.e. not tapered, such that the diameter transition zones would be a single dotted line in the annotated figure below], the at least one of the connection points 32 and 36 is located at the stepped shoulder), the distal section of the core passing into and being encompassed by the tube (see annotated figures 1 and 2 from rejection of claim 1 above)
wherein the outer diameter of the stepped shoulder and an inner diameter of the tube are substantially similar (see annotated figures 1 and 2 from the rejection of claim 1 above; wherein the examiner notes that there is a very small gap between the outer diameter of the core element 28 and the inner diameter of tube element 30, thus making them substantially similar [absent any specific definition of substantially from the specification]); and
wherein an outer diameter of the tube is substantially the same as an outer diameter of the proximal section of the core (see annotated figures 1 and 2 from rejection of claim 1 above; wherein the examiner notes that the outer diameter of the proximal section of core element 28 and outer diameter of tube element 30 are nearly identical, thus making them substantially similar [absent any specific definition of substantially from the specification])
However; Voeller does not explicitly disclose wherein an inner surface of the tube and an outer surface of the stepped shoulder are in contact over the entire length of the stepped shoulder; or that the outer diameter of the proximal section of the core and the outer diameter of the tube deviates less than 1%.
Uihlein teaches a similar guidewire having a stepped shoulder (element 4) on a core wire (element 1) wherein the guidewire includes an outer tubular element (coil spring, element 6) wherein an inner surface of the tubular member and an outer surface of the stepped shoulder are in contact over substantially the entire length of the stepped shoulder (page 3, paragraphs 4 and 5 of translation which describes diameter of d1 as being sized such that the proximal end of the tubular element 6 needs to be pushed onto shoulder element 4 to connect the tubular element to the core wire and help provide torqueability and pushability; see annotated figure 1 from Uihlein below).
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Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Voeller’s guidewire as described in the rejection of claim 1 and as described with regard to claim 18 above so that the inner surface of the tube and an outer surface of the stepped shoulder are in contact over the entire length of the stepped shoulder as taught by Uihlein in order to help ensure a strong connection between the tube and the core wire and improve torqueability and pushability.
Further regarding claims 18-20, the Voeller/Uihlein combination is described above; however, it does not explicitly state the outer diameter of the tube and an outer diameter of the proximal section of the core deviate by less than 1%.
Orr teaches a similar guidewire having a core wire with a proximal end (element 25) having a diameter and a distal section with a tubular element (combined coil elements 20 and 15) wherein the outer diameter of the tube and the outer diameter for the proximal section of the core wire deviate by less than 1% (wherein Orr teaches the outer diameter of the coil and the outer diameter of the proximal section of the core are exactly the same as the core wire proximal section has a 0.356 mm outer diameter and the outer diameter of the coil section is also 0.356 mm; column 3, lines 29-49; figure 1).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the Voeller/Uihlein combination such that the outer diameter of the tube and an outer diameter of the proximal section of the core deviate by less than 1% as taught by Orr as use of a known technique to improve similar devices in the same way (in this case applying Orr’s technique of a uniform outer diameter guidewire along the length of the guidewire to the Voeller/Uihlein combination
Such a modification would teach all of the limitations of instant claims 18.
Further regarding claim 19; the Voeller/Uihlein/Orr combination does not explicitly disclose that the tube (element 30) in the embodiment used in the rejection of claim 18 above includes a plurality of fenestrations that form axially extending beams and circumferentially extending rings.
However, in an alternate embodiment, Voeller discloses the tube (element 46) at the end of the guidewire (element 43) includes a plurality of fenestrations (element 48) wherein the plurality of fenestrations form a plurality of axially extending beams (longitudinally extending parts of the tube) and a plurality of circumferentially extending rings (ring elements of the tube) (paragraph [0043]; figure 10).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to substitute the tube (element 30) at the distal end of the Voeller/Uihlein/Orr combination guidewire with the tube (element 46) at the distal end of the guidewire embodiment in figure 10 as simple substitution of one known element for another to yield a predictable result (in this case, the Voeller/Uihlein/Orr combination core wire with the tube having fenestrations (element 46) of the guidewire from figure 10 of Voeller).
Further regarding claim 20; the Voeller/Uihlein/Orr combination as described in the rejection of claim 18 does not explicitly disclose that the stepped shoulder has an outer diameter that is 30% to 90% of the outer diameter of the proximal section of the core.
Voeller does disclose a stepped shoulder which has a diameter smaller than the outer diameter of the proximal section of the core, but does not disclose any values for the outer diameter of the proximal section of the core or the diameter of the stepped shoulder portion (see figures 1 and 2).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the Voeller/Uihlein/Orr combination guidewire to have a stepped shoulder that has an outer diameter that is 30% to 90% of the outer diameter of the proximal section of the core since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and the device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the Voeller/Uihlein/Orr combination guidewire described in the rejection of claim 18 of would not operate differently with the claimed outer diameter of the stepped shoulder portion being 30% to 90% of the outer diameter of the proximal section of the core and the guidewire would function appropriately having the claimed diameter. Further, it appears that the applicant places no criticality on the range claimed, simply indicating that the diameter “can have” outer diameters within the claimed ranges (see paragraphs [0011] and [0045] of the published specification of the instant application).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADAM J EISEMAN whose telephone number is (571)270-3818. The examiner can normally be reached Monday - Friday (7:00 AM - 4:00 PM).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jacqueline Cheng can be reached at 571-272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ADAM J EISEMAN/ Primary Examiner, Art Unit 3791
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