DETAILED ACTION
Response to Amendment
This action is responsive to applicant’s amendments filed on 5/11/2026.
Claims 1 and 18 are amended.
Claim 15 is cancelled.
Claim 21 is newly presented.
The amendments are in compliance and entered into the record on file.
Response to Arguments
Applicant's amendments and arguments/remarks filed 5/11/2026 with regards to the 35 USC 102 rejection of claims 1-4, 6-9, 13-15 and 18 have been fully considered but are not persuasive. The applicant’s arguments are two-fold. First the applicant argues that Voeller’s core 28 as illustrated clearly does not include a distally facing surface that “is perpendicular to the longitudinal axis of the core” as required by claim 1. The examiner concedes that Voeller’s illustrated embodiment of figures 1 and 2 does not depict the distally facing surface that “is perpendicular to the longitudinal axis of the core” but as noted by the applicant, relies on paragraph [0044] of Voeller which states that the core wire can include tapered or step-wise transitions. The applicant correctly summarizes the examiner’s rejection that an emobodiment with a step-wise transition would result in a distally-facing surface that is perpendicular to the longitudinal axis of the core (as step-wise means that it is a direct change in diameter from one step to another, and therefore the diameter changes immediately from the diameter at the proximal section to the diameter at the shoulder section, as depicted in the annotated figures 1 and 2 of the previous office action and reproduced below). The applicant appears to further argue that Voeller does not disclose a step-wise transition when stating “even if it is assumed, arguendo, that a skilled person would have used a step-wise transition in Voeller’s core…” This is found to be non-persuasive, because such an interpretation does not require an assumption, as step-wise transitions are explicitly disclosed as alternatives to smoothly tapering sections by Voeller in paragraph [0044], “The core may have one or more smoothly tapering sections, or one or more step-wise transitions, or both.” Accordingly, the examiner finds the applicant’s argument that Voeller does not disclose a “distally-facing surface that is perpendicular to the longitudinal axis of the core” to be non-persuasive.
The applicant further argues that even if there was a step-wise transition in Voeller’s core, the amended claims require both a stepped shoulder and one or more tapered shoulders distal of the stepped shoulder, and compares Voeller’s configuration as depicted in the previous rejection to applicant’s figure 4. The applicant further argues that Voeller or the other cited art would have guided the skilled person to use a step-wise transition only at the portion where the tube 30 is coupled to the core 28 while specifically differentiating and using tapered transitions at one or more other locations more distal of the stepped shoulder; and that Voeller’s generic discussion of tapered vs. step-wise transitions could not have guided the skilled person to use both, let alonge the specific arrangement corresponding to the claimed device is non-persuasive. Specifically, the examiner points to the explanation of the previously held rejection of claim 15 which the applicant does not directly address in their arguments, and the cited previously cited section of paragraph [0044] which states “The core may have one or more smoothly tapering sections, or one or more step-wise transitions, or both.” The previous rejection of claim 15 explains the examiner’s position that “Voeller discloses the core, element 28, may have smoothly tapering section, step-wise transitions, or both, and thus contemplates an embodiment having a tapered shoulder section distal to the stepped shoulder identified in the rejection of claim 1; paragraph [0044]; see annotated figures 1 and 2” which is on page 7 of the previous office action. Said another way, the embodiments depicted in figures 1 and 2 of Voeller explicitly depicted two transition sections between the shoulder and the distal section. The specification at paragraph [0044] as previously noted states that these two transition sections may be smoothly tapering sections, step-wise transitions, or both. Thus, the examiner contends that one having ordinary skill viewing figures 1 and 2 of Voeller and reading paragraph [0044] of the specification would consider that Voeller’s disclosure envisages at least 4 embodiments based on figure 1 and 2, as follows:
Embodiment 1: The embodiment as depicted in figures 1 and 2; wherein there are two tapering transitions, one between proximal section to the shoulder section, and the other from the shoulder section to the distal section.
Embodiment 2: A first alternative embodiment to depicted figures 1 and 2, only where both of the diameter transitions step-wise transitions instead of tapering transition.
Embodiment 3: An embodiment where the diameter transitions of annotated figures 1 and 2 from the previous office action includes the first transition from the proximal section to the shoulder section as a smoothly tapering transition and where the second transition from the shoulder section to the distal section as a step-wise transition.
Embodiment 4: An embodiment where the diameter transitions of annotated figures 1 and 2 from the previous office action includes the first transition from the proximal section to the shoulder section as a step-wise transition and where the second transition from the shoulder section to the distal section is a tapering transition.
The examiner notes that embodiment 4 as described here and explained in the previous rejection of claim 15 meets the BRI of the currently amended and presented claim 1 as the distal tapering transition meets the limitation of one or more tapered shoulders distal of the stepped shoulder. Accordingly, the applicant’s arguments that Voeller does not disclose the specific arrangement corresponding to the claimed device is found to be non-persuasive.
Finally, the applicant has amended claims 18-20 and added new claim 21 to recite the limitation “the inner surface of the tube and an outer surface of the stepped shoulder are in contact over substantially the entire length of the stepped shoulder”. The amendment overcomes the previously held 35 USC 102 rejection; however, it is rejected in the body of the office action below under 35 USC 103 in view of previously cited reference DE 4445879 A1 to Uihlein and Voeller as described below as necessitated by the amendment which includes limitations which have not been previously presented.
As such, the applicant’s amendments and arguments have been fully considered, but are non-persuasive to put the application in condition for allowance.
Claim Rejections - 35 USC § 102
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, 6-9, 13 and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by (Voeller et al US 2009/0036834 A1).
Regarding claims 1-4, 6-9, 13 and 14; 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 or more 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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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]).
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 15; Voeller discloses the distal section of the core further comprises one or more tapered shoulders distal of the stepped shoulder (Voeller disclose the core, element 28, may have smoothly tapering section, step-wise transitions, or both, and thus contemplates an embodiment having a tapered shoulder section distal to the stepped shoulder identified in the rejection of claim 1; paragraph [0044]; see annotated figures 1 and 2).
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 10-12 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Voeller (as cited in the 35 USC 102 rejection above).
Regarding claims 10 and 11; Voeller is descried in the rejection of claim 1 above; however, Voeller 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 substitute the tube (element 30) at the distal end of the guidewire in figures 1 or 2 with the tube (element 46) at the distal end of the guidewire in figure 10 as simple substitution of one known element for another to yield a predictable result (in this case, a guidewire having the core of the guidewire of figures 1 and 2 with the tube (element 46) of the guidewire from figure 10).
Regarding claim 12; Voeller 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 Voeller’s 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 guidewire of Voeller 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).
Regarding claim 17; Voeller 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 Voeller’s 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 guidewire of Voeller 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 as applied to claim 1 above, and further in view of Davis et al (US 2020/0222672 A1).
Regarding claim 5, Voeller 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 hydrophilic coating and that hydrophilic coatings are suitable 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; Veoller is described in the rejection of claim 1 above; however, Voeller 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 Voeller’s 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 18-21 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).
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])
Regarding claim 21; Voeller is described in the rejection of claim 1 above.
However, with regards to claims 18-21; 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.
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. Such a modification would teach all of the limitations of instant claims 18 and 21.
Further regarding claim 19; the Voeller/Uihlein 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 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, a guidewire having the core of the guidewire of figures 1 and 2 with the tube having fenestrations (element 46) of the guidewire from figure 10).
Further regarding claim 20; the Voeller/Uihlein 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 Voeller’s 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 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
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 ADAM J EISEMAN whose telephone number is (571)270-3818. The examiner can normally be reached Monday - Friday (7:00 AM - 4:00 PM).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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