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 .
Applicant' s arguments, filed 4/20/2026, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 4/20/2026, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1-8 are the currently pending claims hereby under examination. Claims 1 and 3 have been amended.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Biggins (US-20070244413-A1), hereto referred as Biggins, and further in view of Henderson et al. (US-20160022215-A1), hereto referred as Henderson.
Regarding claim 1, Biggins teaches that a guide wire comprises: a core shaft having a distal end portion and a proximal end portion (Biggins, ¶[0025], “Elongate shaft 102 may be a unitary shaft from proximal end 104 to distal end 205, wherein distal region 106 of shaft 102 undergoes a centerless grinding process to fabricate reduced-diameter core wire portion 110", Biggins describes the core guidewire as having a shaft with a proximal end and a distal end which corresponds having a proximal end portion and a distal end portion); wherein the distal end portion includes a plurality of sets (Biggins, FIG. 5-6; ¶[0028], “a distal tip segment that includes a plurality of flat drops spaced from each other by short frusto-conical or cylindrical linking portions”, Biggins describes a distal tip segment having multiple repeated flat drops that are separated by linking portions which corresponds to the distal end portion including a plurality of sets); each set including, in order from a most distal end side: a first region having a flat shape in cross section and having a major axis and a minor axis (Biggins, FIG. 5-6; ¶[0024], “Core wire tip segment 212 is provided with proximal and distal flat drops 314, 316, which are axially-spaced flattened portions of core wire 110”, Biggins describes flattened portions of a core wire in the distal tip segment which corresponds to a first region having a flat shape in cross section; ¶[0026]: “distal flat drop 316 has a first planar surface 518 substantially in parallel with an opposing second planar surface 520. Similarly, proximal flat drop 314 has a first planar surface 522 substantially in parallel with an opposing second planar surface 524” and “Length, width and thickness dimensions of proximal and distal flat drops 314, 316 may be the same or different”, Biggins teaches flattened portions having opposing planar surfaces and width and thickness dimensions, which correspond to a flattened cross section having major and minor axis (see figures 5-6)); and a second region having a circular shape in cross section and having a flexural rigidity higher than a flexural rigidity of the first region (Biggins, ¶[0026], “Distal flat drop 316 is axially spaced from proximal flat drop 314 by a linking portion 526, which may be frusto-conical or cylindrical in shape”, Biggins describes a linking portion between adjacent flattened portions that may be cylindrical which corresponds to a second region having a circular shape in cross section; ¶[0027], “Proximal flat drop 314 provides increased flexibility of distal tip section 212”, Biggins explains that the flattened portion provides increased flexibility which corresponds to the flattened portion having lower flexural rigidity than the adjacent non-flattened portions of the core wire including the cylindrical linking portion).
Also regarding claim 1, Biggins does not explicitly demonstrate that the major axes of the respective first regions are oriented in an identical direction about a longitudinal axis of the guide wire. Rather, Biggins teaches a distal tip segment that includes a plurality of flat drops spaced from each other by short frusto-conical or cylindrical linking portions and illustrates embodiments in which planar surfaces of the flat drops are disposed substantially perpendicular to each other such that the planar surfaces are not in the same plane (Biggins, ¶[0026]; ¶[0028]). Biggins further explains that, in other embodiments, planar surfaces of adjacent flat drops may be disposed at an angle of less than 90° relative to each other (Biggins, ¶[0026]). Thus, Biggins expressly contemplates a range of angular orientations between adjacent flat drops rather than limiting the flat drops to an orthogonal configuration. However, while Biggins indicates that orientations other than perpendicular are contemplated, Biggins does not explicitly describe or exemplify a configuration in which the major axes of the respective first regions are oriented in an identical direction about a longitudinal axis of the guide wire.
Henderson teaches a guidewire core that includes multiple flattened sections formed with a consistent orientation along the length of the core wire. Specifically, Henderson explains that “the core wire 300 can include one flattened section, or three or more flattened sections in different embodiments” (Henderson, FIG. 6a-d, 13; ¶[0060]). Henderson further describes that, for each flattened section, “the planar regions 308, 310 are disposed on top and bottom surfaces of the respective flattened sections 304, 306” (Henderson, ¶[0060]), indicating that the flattened sections are formed with corresponding planar surfaces oriented in the same direction relative to the longitudinal axis of the core wire. In this configuration, each flattened section has the same major-axis orientation about the longitudinal axis, rather than being rotated relative to adjacent flattened sections. Henderson also explains that portions of the core wire may retain a circular cross section, stating that “the cross-sectional profile of the reduced diameter section 302 is substantially circular” (Henderson, ¶[0061]). Thus, Henderson teaches a guidewire core having multiple flattened regions with major axes orientated in an identical direction about the longitudinal axis of the guide wire while also teaching that other portions of the core wire can have a circular cross section. Henderson further explains that the distal tip shapeability is relevant to steering the guide wire through tortuous anatomy (Henderson, ¶[0005]), which confirms that Henderson’s flattened distal core-wire sections are in the same guidewire distal-tip context as Biggin’s flattened distal tip regions.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Biggins in view of Henderson to configure the plurality of flat drops so that the major axes of the respective first regions are oriented in an identical direction about a longitudinal axis of the guide wire. Such a modification would have been possible by forming the flat drops of Biggins with the same orientation during manufacture, rather than rotating the core wire between forming successive flat drops, consistent with Henderson’s teaching of multiple flattened sections having planar regions disposed on corresponding top and bottom surfaces. The benefit of the combination would have been to provide predictable bending response associated with commonly orientated flattened sections while maintaining the alternating flattened and circular regions taught by Biggins. The modification follows from Biggin’s recognition that flat-drop orientation affects distal guidewire bending and Henderson’s confirmation that commonly orientated flattened sections were known in guidewire distal-tip constructions where shapeability and steering are relevant.
Regarding claim 2, the modified Biggins teaches that each of the second regions has a first portion, a second portion located on a proximal end side of the first portion and having an outer diameter larger than an outer diameter of the first portion, and a tapered portion located between the first portion and the second portion and being decreasingly tapered from the second portion toward the first portion (Biggins, FIGS. 5–6, ¶[0026], “Distal flat drop 316 is axially spaced from proximal flat drop 314 by a linking portion 526, which may be frusto-conical or cylindrical in shape”, Biggins teaches a linking portion 526 between flat drops that may include cylindrical and frusto-conical geometry, and FIGS. 5–6 depict linking portion 526 as a round, larger outer diameter portion and further depict an unlabeled shoulder region adjacent each flat drop that tapers from the larger round portion toward the smaller profile adjacent the flat drop, corresponding to the claimed second portion, tapered portion, and first portion of the second region; ¶[0028], “…and/or one or more linking portions that are tapered”, Biggins further teaches that one or more linking portions are tapered, and FIGS. 5–6 show the tapered shoulder region between the round portion of linking portion 526 and the adjacent flat drop, consistent with the tapered portion being decreasingly tapered from the larger-diameter portion toward the smaller portion adjacent the flat drop).
Regarding claim 3, the modified Biggins does not fully teach that side surfaces of each of the first regions in a minor axis direction are smooth surfaces, and side surfaces of each of the first regions in a major axis direction are circular arc surfaces. The modified Biggins teaches flat drops having opposing planar surfaces, i.e., “distal flat drop 316 has a first planar surface 518 substantially in parallel with an opposing second planar Surface 520. Similarly, proximal flat drop 314 has a first planar surface 522 substantially in parallel with an opposing second planar Surface 524” (Biggins, ¶[0026], “distal flat drop 316 has a first planar surface 518 substantially in parallel with an opposing second planar Surface 520. Similarly, proximal flat drop 314 has a first planar surface 522 substantially in parallel with an opposing second planar Surface 524”). However, while these “planar surface[s]” in the modified Biggins connote flat, finished faces (and FIGS. 5–6 depict those flat faces and rounded side contours), the modified Biggins does not explicitly describe the side surfaces of the first regions in the minor axis direction as “smooth surfaces” or the side surfaces in the major axis direction as “circular arc surfaces”.
Henderson further teaches flattened sections having defined planar regions on opposite sides, e.g., “the planar regions 308, 310 are disposed on top and bottom surfaces of the respective flattened sections 304,306” (Henderson, ¶[0060], “the planar regions 308, 310 are disposed on top and bottom surfaces of the respective flattened sections 304,306”; see also ¶[0097]), and when combined with the figures, supports that the minor axis direction side faces are planar and smooth surfaces (Henderson, FIG. 6a-d). Henderson also teaches that “the cross-sectional profiles of the flattened portions 304, 306 can be substantially oval-shaped” (Henderson, ¶[0061], “the cross-sectional profiles of the flattened portions 304, 306 can be substantially oval-shaped”), which corresponds to the side surfaces in the major axis direction being rounded (i.e., circular arc type side contours) rather than sharp corners.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the modified Biggins in view of Henderson to form the first regions such that side surfaces in the minor axis direction are smooth surfaces and side surfaces in the major axis direction are circular arc surfaces. Such a modification would have been possible by manufacturing the flat drops of the modified Biggins using known guidewire core forming techniques (such as grinding and/or swaging) to create opposing planar regions and then applying edge rounding during the same forming operation or a subsequent finishing operation to produce rounded side surfaces, consistent with Henderson’s teaching of planar regions on top and bottom surfaces and a substantially oval or rectangular-with-rounded-sides profile. This would have been a straightforward design selection because it involves selecting the cross-sectional profile of the flattened regions during manufacture while maintaining the longitudinal arrangement of flat drops and linking portions taught by the modified Biggins. The benefit of the combination would have been to reduce sharp edges and stress concentrations at the flattened regions while preserving the desired planar surface characteristics for guidewire performance and manufacturability.
Regarding claim 4, the modified Biggins teaches that the distal end portion includes a tapered portion located between a most proximal end side of the plurality of sets and the proximal end portion of the core shaft (Biggins, FIG. 2; ¶[0024], “distal region 106 of shaft 102 includes a tapered core wire 110 having a distal tip segment 212. Core wire tip segment 212 is provided with proximal and distal flat drops 314, 316”; Biggins teaches a distal region that includes a tapered core wire and, further distally, a distal tip segment provided with multiple flat drops, which corresponds to a tapered portion located proximally of the plurality of flat-drop sets; ¶[0025], “Various centerless grinding steps may be implemented to achieve a stepped-down taper in core wire portion 110 to thereby incrementally increase its flexibility as it extends distally”; Biggins teaches a tapered portion formed in the core wire portion as it extends distally, which corresponds to a tapered portion positioned between the most proximal flat-drop set and the proximal end portion of the core shaft).
Regarding claim 5, the modified Biggins teaches that the distal end portion includes two sets (Biggins, FIGS. 5–6, ¶[0026], “Distal flat drop 316 is axially spaced from proximal flat drop 314 by a linking portion 526”, Biggins teaches a distal flat drop and a proximal flat drop arranged along the distal tip segment, and FIGS. 5–6 depict two flat drops each associated with an intervening linking portion, corresponding to two sets of flat and circular regions in the distal end portion).
Regarding claim 6, the modified Biggins teaches that the distal end portion includes a plurality of sets, but does not explicitly teach that the distal end portion includes three sets. The modified Biggins teaches a guidewire core wire region having “a distal tip segment that includes a plurality of flat drops spaced from each other by short frusto-conical or cylindrical linking portions” (Biggins, ¶[0028]). While the modified Biggins thereby teaches a plurality of sets along the distal tip segment, meaning at least two sets and potentially more, the modified Biggins does not expressly specify that the distal end portion includes three sets.
Henderson teaches that “it is understood that the core wire 300 can include one flattened section, or three or more flattened sections in different embodiments” (Henderson, ¶[0060]). Henderson’s teaching of “three or more flattened sections” provides express support for selecting three flattened sections, corresponding to three sets of flat regions along the distal end portion.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the modified Biggins in view of Henderson to provide the distal end portion including three sets by forming three flat drops in succession along the distal tip segment instead of two. Such a modification would have been possible because the modified Biggins already discloses that the distal tip segment may include “a plurality of flat drops” spaced from each other by linking portions (Biggins, ¶[0028]), and Henderson teaches that three or more flattened sections are a contemplated alternative embodiment (Henderson, ¶[0060]). Implementing three sets would involve repeating the flat-drop and linking-portion pattern taught by the modified Biggins an additional time along the distal tip segment while maintaining the same core wire construction and distal-region geometry. The benefit of the combination would have been to provide additional flexibility-tuning and bend-control locations along the distal end portion, enabling a designer to tailor distal tip performance for a desired balance of steerability and support.
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Biggins (US-20070244413-A1), hereto referred as Biggins, and further in view of Henderson et al. (US-20160022215-A1), hereto referred as Henderson, and further in view of Shireman et al. (US-20070123805-A1), hereto referred as Shireman.
The modified Biggins teaches claim 1 as described above.
Regarding claim 7, the modified Biggins does not teach that the flat shape is an oval shape or an elliptical shape having an outline that is entirely composed of curves. Rather, the modified Biggins teaches flat drops having opposing planar surfaces (Biggins, ¶[0026], “distal flat drop 316 has a first planar surface 518 substantially in parallel with an opposing second planar Surface 520. Similarly, proximal flat drop 314 has a first planar surface 522 substantially in parallel with an opposing second planar Surface 524”). However, the modified Biggins does not specify that the flat shape is an oval shape or an elliptical shape having an outline that is entirely composed of curves.
Shireman teaches that “portions of the guidewire section 16 can be flattened, for example, to provide for desired flexibility characteristics” (Shireman, ¶[0045]), and further teaches that “the cross sectional shape of guidewire sections 14/16 may be oval” (Shireman, ¶[0040]), which together correspond to selecting an oval or elliptical outline composed entirely of curves for a flattened region in order to alter flexural rigidity while avoiding distinct planar faces.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the modified Biggins in view of Shireman to form the flat drops with a substantially oval or elliptical cross-sectional profile having an outline that is entirely composed of curves. Such a modification would have been possible by forming the flat drop regions of the modified Biggins using an oval cross-sectional profile instead of opposing planar faces, which would merely require controlling the grinding, swaging, or rolling process used to form the flattened regions so that material removal or deformation follows a continuous curved perimeter rather than creating planar surfaces, while leaving the axial spacing, lengths, and linking portions of the flat drops unchanged as taught by the modified Biggins. The benefit of the combination would have been to provide a flattened region without sharp edges while maintaining distal tip flexibility and steerability.
Regarding claim 8, the modified Biggins does not teach that the flat shape is an oval shape or an elliptical shape having an outline that does not have a flat surface. Rather, the modified Biggins teaches flat drops having opposing planar surfaces (Biggins, ¶[0026], “distal flat drop 316 has a first planar surface 518 substantially in parallel with an opposing second planar Surface 520. Similarly, proximal flat drop 314 has a first planar surface 522 substantially in parallel with an opposing second planar Surface 524”). However, the modified Biggins does not teach that the flat shape is an oval shape or an elliptical shape having an outline that does not have a flat surface because the flat drops are defined by planar surfaces.
Shireman teaches that teaches that “portions of the guidewire section 16 can be flattened, for example, to provide for desired flexibility characteristics” (Shireman, ¶[0045]), and further teaches that “the cross sectional shape of guidewire sections 14/16 may be oval” (Shireman, ¶[0040]), which together correspond to selecting an oval or elliptical cross-sectional geometry having a continuously curved outline without flat surfaces for a flattened region to alter flexural rigidity.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the modified Biggins in view of Shireman to form the flat drops with an oval or elliptical cross-sectional profile having an outline that does not have a flat surface. Such a modification would have been possible by forming the flat drop regions of the modified Biggins using an oval or elliptical cross-sectional profile instead of opposing planar faces, which would merely require controlling the grinding, swaging, or rolling process used to form the flattened regions so that material removal or deformation follows a continuous curved perimeter without forming planar faces, while leaving the axial spacing, lengths, and linking portions of the flat drops unchanged as taught by the modified Biggins. The benefit of the combination would have been to reduce edge-related stress concentrations and improve trackability while maintaining distal tip flexibility and steerability.
Response to Arguments
Information Disclosure Statement
Applicant's arguments filed 4/20/2026, page 4, regarding the previous Information Disclosure Statement have been fully considered and are persuasive. The previous objections to the IDS have been withdrawn.
35 U.S.C. §112(b)
Applicant's arguments filed 4/20/2026, page 5, regarding the previous 112(b) Rejections of claims 1-8 have been fully considered and are persuasive. The previous 112(b) rejections have been withdrawn.
35 U.S.C. §103
Applicant's arguments filed 4/20/2026, pages 5-7, regarding the previous 103 Rejections of claims 1-8 have been fully considered but are not persuasive as shown below.
Applicant’s Argument: Applicant argues that Biggins does not disclose or suggest aligning the flat drops in the same direction because Biggins describes flat drops arranged with respective planar surfaces substantially orthogonal to each other, but asserts that Biggins still requires the flat drops to be arranged out of plane rather than in an identical direction.
Examiner’s Response: Applicant’s argument has been considered but is not persuasive. Biggins is not limited to a single fixed orthogonal relationship between the flat drops. Rather, Biggins expressly recognizes that the angular relationship between the planar surfaces of adjacent flat drops may be varied. Biggins describes an embodiment in which the planar surfaces of distal flat drop 316 are substantially perpendicular to the planar surfaces of proximal flat drop 314, but Biggins also states that, in other embodiments, the planar surfaces of distal flat drop 316 may be disposed at an angle of less than 90 degrees to the planar surfaces of proximal flat drop 314 (Biggins, ¶[0026]). That disclosure does not recite a lower angular bound or require that the less-than-90-degree embodiment remain non-coplanar. Further, where Biggins intends to describe out-of-plane flat drops, Biggins expressly uses more limiting language, stating that the planar surfaces of adjacent flat drops are disposed at an angle to each other “such that the surfaces are not in the same plane” (Biggins, ¶[0028]). Thus, the broader less-than-90-degree disclosure in ¶[0026], when read with Biggins’s express discussion of angular orientation, shows that Biggins recognizes flat-drop orientation as a variable affecting the bending behavior of the guidewire distal tip segment.
Applicant’s Argument: Applicant argues that Biggins and Henderson are directed to fundamentally different and incompatible objectives because Biggins allegedly seeks multi-directional flexibility, whereas Henderson allegedly seeks preferential bending in a single direction.
Examiner’s Response: Applicant’s argument has been considered but is not persuasive. Applicant is correct that Biggins describes advantages associated with orthogonal or out-of-plane flat drops, including multi-directional flexibility. However, that does not negate the rejection because the rejection is not premised on Biggins being limited to its preferred perpendicular embodiment, nor does the rejection require Henderson to be identical to Biggins. Biggins and Henderson both concern guidewire core-wire constructions in which flattened sections are used to affect the flexibility, bending behavior, and performance of the distal portion of a guidewire. Biggins teaches that the angular relationship between adjacent flat drops affects the bending behavior of the distal tip segment, including bending in different directions depending on the orientation of the flat drops (Biggins, ¶[0026]-¶[0028]). Biggins also states that, in other embodiments, the planar surfaces of distal flat drop 316 may be disposed at an angle of less than 90 degrees to the planar surfaces of proximal flat drop 314, without reciting a lower angular bound or requiring that those surfaces remain out of plane (Biggins, ¶[0026]). This is particularly relevant because Biggins uses more limiting language elsewhere when it intends to require an out-of-plane relationship, stating that the planar surfaces of adjacent flat drops are disposed at an angle to each other “such that the surfaces are not in the same plane” (Biggins, ¶[0028]). Henderson likewise teaches a guidewire having multiple flattened core-wire sections in the distal portion, with corresponding planar regions disposed on top and bottom surfaces of the respective flattened sections (Henderson, ¶[0060]). Henderson further explains that it can be important for a distal guidewire tip to be shapeable so that the guidewire can be steered through tortuous anatomy, and that flattened sections provide a smooth transition between the core wire and shaping ribbon (Henderson, ¶[0005], ¶[0008]). Thus, Henderson shows commonly oriented flattened sections in the same guidewire distal-tip context in which core-wire shape, tip shaping, and steering through tortuous anatomy are relevant. Thus, Henderson is not being used as an unrelated or different-purpose teaching. Rather, Henderson is consistent with Biggins’s recognition that flat-drop orientation is a variable affecting bending behavior. The fact that Biggins emphasizes a multi-directional bending profile in one embodiment does not make a commonly oriented configuration incompatible with Biggins’s broader disclosure of less-than-90-degree arrangements that do not expressly exclude a common orientation.
Applicant’s Argument: Applicant argues that modifying Biggins in view of Henderson would destroy the purpose or principle of operation of Biggins because aligning the flattened portions would eliminate the multi-directional flexibility achieved by Biggins’s orthogonal flat drops.
Examiner’s Response: Applicant’s argument has been considered but is not persuasive. Applicant is correct that the orthogonal or out-of-plane embodiment of Biggins is described as providing multi-directional flexibility. However, the proposed modification would not render Biggins inoperable, nor would it destroy Biggins’s general guidewire function. Biggins teaches a guidewire distal tip construction having flattened portions and higher-rigidity linking portions to provide a flexible distal tip segment while maintaining useful column strength and torque transmission characteristics (Biggins, ¶[0024]-¶[0028]). Orienting the major axes of the flat drops in an identical direction, as taught by Henderson, would still leave the modified structure with a core shaft having flattened regions and circular or frusto-conical linking regions of higher flexural rigidity. The modification would change the selected bending profile from the multi-directional profile emphasized in Biggins’s orthogonal embodiment to a bending response associated with commonly oriented flattened sections, but changing the selected bending profile is not the same as rendering the guidewire unsatisfactory for its intended purpose. Moreover, Biggins itself is not limited to the orthogonal embodiment because Biggins also teaches less-than-90-degree arrangements without reciting a lower bound, and Biggins uses express “not in the same plane” language elsewhere when it intends to require that relationship (Biggins, ¶[0026], ¶[0028]). Biggins already recognizes that flat-drop orientation affects distal bending behavior, and Henderson shows that commonly oriented flattened sections were known in the same guidewire distal-tip context, and further explains that distal tip shapeability is important so that the guidewire can be steered through tortuous anatomy (Henderson, ¶[0005], ¶[0060]). Accordingly, the modification represents a predictable use of known flattened-core orientation principles to obtain a desired bending characteristic while retaining the general distal-tip construction relied upon from Biggins.
Applicant’s Argument: Applicant argues that the rejection is based on impermissible hindsight reconstruction because the Office Action allegedly modifies Biggins only to arrive at the claimed identical orientation of the major axes.
Examiner’s Response: Applicant’s argument has been considered but is not persuasive. The rationale for the modification comes from the teachings of the applied references themselves, not from Applicant’s disclosure. Biggins recognizes that flattened distal tip regions affect guidewire flexibility and bending behavior, and further recognizes that the angular relationship between adjacent flat drops may be selected to control the direction or directions in which the distal tip segment bends (Biggins, ¶[0026]-¶[0028]). Although Biggins emphasizes advantages of orthogonal or out-of-plane flat drops, Biggins’s disclosure is not limited to the substantially perpendicular embodiment because Biggins also teaches less-than-90-degree angular arrangements without reciting a lower bound or requiring that the adjacent flat drops remain out of plane (Biggins, ¶[0026]). This is particularly relevant because Biggins uses more limiting language elsewhere when it intends to require an out-of-plane relationship, stating that the planar surfaces of adjacent flat drops are disposed at an angle to each other “such that the surfaces are not in the same plane” (Biggins, ¶[0028]). Henderson is directed to the same general guidewire design concern because Henderson also uses multiple flattened sections of a core wire in the distal portion of a guidewire to control bending behavior, including commonly oriented flattened sections having corresponding planar regions disposed on top and bottom surfaces of the respective flattened sections (Henderson, ¶[0060]). Thus, the proposed modification is not based on selecting Henderson’s flattened sections in isolation from their function, and Henderson is not being used to introduce a disconnected concept absent from Biggins. Rather, Henderson confirms that commonly oriented flattened sections were known in the guidewire art in the same distal-tip context in which tip shapeability and steering through tortuous anatomy are relevant, while Biggins already identifies the orientation of such flattened regions as affecting distal guidewire bending (Henderson, ¶[0005], ¶[0060]). It would have been prima facie obvious before the effective filing date of the claimed invention to have modified Biggins in view of Henderson to orient the major axes of the flat drops in an identical direction about the longitudinal axis of the guidewire in order to obtain a predictable bending response associated with commonly oriented flattened sections. The modification follows from Biggins’s recognition that flat-drop orientation affects distal guidewire bending and Henderson’s confirmation that commonly oriented flattened sections were known in guidewire distal-tip constructions where shapeability and steering are relevant, rather than impermissible hindsight reconstruction.
Applicant’s Argument: Applicant argues that, for at least the reasons presented with respect to claim 1, claim 1 and its dependent claims would not have been rendered obvious by the applied combinations.
Examiner’s Response: Applicant’s argument has been considered but is not persuasive. Applicant has not presented separate arguments directed to the additional limitations of dependent claims 2-8. Accordingly, the dependent claims stand or fall with claim 1 to the extent Applicant relies on the same arguments addressed above. The rejections of dependent claims 2-8 are maintained for the reasons set forth in the claim rejections, including the specific teachings of Biggins, Henderson, and Shireman applied to the additional dependent claim limitations.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/AARON MERRIAM/Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791
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