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 .
Claims 1-8 are the currently pending claims hereby under examination.
Information Disclosure Statement
The information disclosure statement filed 11/24/2023 fails to comply with 37 CFR 1.98(a)(3)(i) because it does not include a concise explanation of the relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of each reference listed that is not in the English language. It has been placed in the application file, but the information referred to therein has not been fully considered. Specifically, under the Foreign Patent Documents section, citation number 3 (“2013-215566 JP A 2013-10-24 Covidien LP”) and citation number 4 (“3940161 JP B1 2007-07-04 Asahi Intecc Co Lid”) are not in the English language, were not accompanied by an English translation, were not accompanied by an English Abstract, and were not accompanied by a concise explanation of their relevance. These references have not been considered.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-8 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth the subject matter which the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the applicant regards as the invention.
Claim 1 recites “flat shape directions of the respective first regions are identical” in lines 3-4, but “flat shape directions” is indefinite because the claim does not specify how a direction is defined for the cross section of the first region, such as whether the direction is an orientation of a major axis for an oval or elliptical profile, a normal direction to planar faces, or another parameter. The Examiner is interpreting “flat shape directions” to mean that the first regions are oriented in the same rotational orientation about the guide wire longitudinal axis. Additionally, "flat shape" is interpreted to mean a non-circular cross section having a major dimension and a minor dimension. However, this interpretation is not compelled by the claim language and the phrase permits multiple reasonable interpretations, rendering the claim indefinite.
Claims 2-8 are rejected by virtue of their dependence from claim 1.
Claim 3 recites “side surfaces of each of the first regions in a plate thickness direction” and “side surfaces of each of the first regions in a plate width direction” in lines 1-2, but the phrases are indefinite because claim 1 does not define what constitutes a “plate” for a given cross section, and the claim does not provide an objective reference for determining “plate thickness” and “plate width” directions. The Examiner is interpreting the “plate thickness direction” and “plate width direction” to refer to mutually perpendicular directions corresponding to a minor dimension and a major dimension of the flattened cross section. However, because the claim does not establish how these directions are determined for the claimed profiles, the scope is indefinite under 35 U.S.C. § 112(b).
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 (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); 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 flat shape directions of the respective first regions are identical. 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 planar surfaces of adjacent flat drops are disposed with identical flat shape directions as recited in the claim.
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 flat shape direction, 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 identical flat shape directions, while also teaching that other portions of the core wire can have a circular cross section.
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 flat shape directions of the respective first regions are identical. 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 directional bending and consistent steering characteristics along the distal tip segment while maintaining the alternating flattened and circular regions taught by Biggins.
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 plate thickness direction are smooth surfaces, and side surfaces of each of the first regions in a plate width 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 plate thickness direction as “smooth surfaces” or the side surfaces in the plate width 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 plate thickness 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 plate width 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 plate thickness direction are smooth surfaces and side surfaces in the plate width 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 3, the modified Biggins partially teaches that side surfaces of each of the first regions in a plate thickness direction are smooth surfaces, and side surfaces of each of the first regions in a plate width direction are circular arc surfaces. Specifically, 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 plate thickness direction as “smooth surfaces” or the side surfaces in the plate width 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 plate thickness direction side faces are planar and smooth surfaces (Henderson, FIG. 6a-d, 17b). 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 plate width 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 plate thickness direction are smooth surfaces and side surfaces in the plate width 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 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.
Conclusion
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/AARON MERRIAM/Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791