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 .
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
No claim limitation has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-3, 8-9, and 13-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nabeshima et al. (US Publication No. 2016/0375226 A1), further in view of Deckard et al. (US Publication No. 2012/0165789 A1).
Regarding claim 1, Nabeshima et al. discloses a guidewire, comprising:
an elongate core member (2) having a proximal end region (23) and a distal end region (21) (see [0029] – “The wire main body 2 is constituted of an elongated body which forms an elongated shape and has flexibility (i.e., is flexible). This wire main body 2 has a small-diameter portion 21, a tapered portion 22, and a large-diameter portion 23 which are sequentially disposed from a distal end toward a proximal end (i.e., the small-diameter portion 21 is distal to the tapered portion 22 and the tapered portion 22 is distal to the large-diameter portion 23”);
a coil member (4) surrounding and disposed along the distal end region of the elongate core member (see Figure 3 and [0078] – “In the embodiment depicted in FIG. 3, a distal portion of an inner coil 4 is fixed to a small-diameter portion 21 of a wire main body 2 through a fixation material 11 along with a distal portion of an outer coil 3”); and
an actuation member (5) coupled to the coil member and disposed between the elongate core member and the coil member (see Figures 1-3 and [0065] – “The operation member 5 is a member which performs an operation of changing the interval p. The operation member 5 is constituted of a tube through which the wire main body 2 is inserted. The total length of the operation member 5 is shorter than that of the wire main body 2. The distal portion 51 of the operation member 5 is interlocked and fixed to the proximal portion of the inner coil 4”), the actuation member extending proximal of the coil member, the actuation member configured to shift the coil member between a first configuration (see Figure 1) and a compressed configuration (see Figure 2).
It is noted Nabeshima et al. does not specifically teach the actuation member is configured to be proximally retracted to apply compressive forces onto the coil member. However, Deckard et al. teaches the actuation member is configured to be proximally retracted to apply compressive forces onto the coil member (see Figures 1-2 and [0032] – “FIG. 2 shows the wire guide 102 of FIG. 1 with the spring 108 in a compressed state. When a user pulls the mandrel 104 in a proximal direction relative to the cannula 106, the distal tip 110 retracts towards the cannula 106 against the natural bias of the spring 108 and the spring 108 is compressed between the distal tip 110 and the cannula 106”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the guidewire of Nabeshima et al. to include the actuation member is configured to be proximally retracted to apply compressive forces onto the coil member, as disclosed in Deckard et al., so as to position the coil member in a loaded state near an occlusion to pass through and clear the occlusion (see Deckard et al.: [0052]).
Regarding claim 2, Nabeshima et al. discloses a sleeve (13) surrounding the coil member (see [0043] – “In addition, the hydrophilic layer 13 coated with a hydrophilic material is provided on an outer circumferential portion 33 of the outer coil 3”).
Regarding claim 3, Nabeshima et al. discloses the sleeve has a constant outer diameter (see Figures 1-3).
Regarding claim 8, Nabeshima et al. discloses a tip member disposed adjacent to a distal end of the coil member (see [0078] – “In the embodiment depicted in FIG. 3, a distal portion of an inner coil 4 is fixed to a small-diameter portion 21 of a wire main body 2 through a fixation material 11 along with a distal portion of an outer coil 3. In this manner, the fixation material 11 fixes both of the inner coil 4 and the outer coil 3 in this embodiment”).
Regarding claim 9, Nabeshima et al. discloses a guidewire, comprising:
an elongate core member (2) having a proximal end region (23) and a distal end region (21) (see [0029] – “The wire main body 2 is constituted of an elongated body which forms an elongated shape and has flexibility (i.e., is flexible). This wire main body 2 has a small-diameter portion 21, a tapered portion 22, and a large-diameter portion 23 which are sequentially disposed from a distal end toward a proximal end (i.e., the small-diameter portion 21 is distal to the tapered portion 22 and the tapered portion 22 is distal to the large-diameter portion 23”);
a coil member (4) surrounding and disposed along the distal end region of the elongate core member such that the proximal end region of the elongate core member extends proximal of the coil member (see Figure 3 and [0078] – “In the embodiment depicted in FIG. 3, a distal portion of an inner coil 4 is fixed to a small-diameter portion 21 of a wire main body 2 through a fixation material 11 along with a distal portion of an outer coil 3”); and
an actuation member (5) secured to the coil member (see Figures 1-3 and [0065] – “The operation member 5 is a member which performs an operation of changing the interval p. The operation member 5 is constituted of a tube through which the wire main body 2 is inserted. The total length of the operation member 5 is shorter than that of the wire main body 2. The distal portion 51 of the operation member 5 is interlocked and fixed to the proximal portion of the inner coil 4”), the actuation member extending proximal of the coil member along the proximal end region of the elongate core member (see Figures 1-3), the actuation member configured to shift the coil member between a first configuration (see Figure 1) and a compressed configuration (see Figure 2).
It is noted Nabeshima et al. does not specifically teach the actuation member is configured to be proximally retracted to apply compressive forces onto the coil member. However, Deckard et al. teaches the actuation member is configured to be proximally retracted to apply compressive forces onto the coil member (see Figures 1-2 and [0032] – “FIG. 2 shows the wire guide 102 of FIG. 1 with the spring 108 in a compressed state. When a user pulls the mandrel 104 in a proximal direction relative to the cannula 106, the distal tip 110 retracts towards the cannula 106 against the natural bias of the spring 108 and the spring 108 is compressed between the distal tip 110 and the cannula 106”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the guidewire of Nabeshima et al. to include the actuation member is configured to be proximally retracted to apply compressive forces onto the coil member, as disclosed in Deckard et al., so as to position the coil member in a loaded state near an occlusion to pass through and clear the occlusion (see Deckard et al.: [0052]).
Regarding claim 13, Nabeshima et al. discloses a sleeve (13) disposed over the coil member (see [0043] – “In addition, the hydrophilic layer 13 coated with a hydrophilic material is provided on an outer circumferential portion 33 of the outer coil 3”).
Regarding claim 14, Nabeshima et al. discloses a tip member disposed adjacent to a distal end of the coil member (see [0078] – “In the embodiment depicted in FIG. 3, a distal portion of an inner coil 4 is fixed to a small-diameter portion 21 of a wire main body 2 through a fixation material 11 along with a distal portion of an outer coil 3. In this manner, the fixation material 11 fixes both of the inner coil 4 and the outer coil 3 in this embodiment”).
Regarding claim 15, Nabeshima et al. discloses the distal end region of the elongate core member includes at least one tapered region (see [0029] – “This wire main body 2 has a small-diameter portion 21, a tapered portion 22, and a large-diameter portion 23 which are sequentially disposed from a distal end toward a proximal end (i.e., the small-diameter portion 21 is distal to the tapered portion 22 and the tapered portion 22 is distal to the large-diameter portion 23)”). Deckard et al. also teaches the distal end region of the elongate core member includes at least one tapered region (see [0025] – “In one implementation, the mandrel 104 has a cross-sectional area that diminishes gradually or stepwise at increasing distances from the proximal end of the wire guide 102 such that the mandrel 104 tapers to a smaller diameter toward its distal end”)
Regarding claim 16, Deckard et al. teaches a proximal end of the coil member is secured to the elongate core member proximal of the at least one tapered region (see [0031] – “Alternatively, the proximal end (or other proximal portion) of the spring 108 may be fixed to the mandrel 104”).
Regarding claim 17, Nabeshima et al. discloses a guidewire, comprising:
an elongate core member (2) having a proximal end region (23) and a distal end region (21) (see [0029] – “The wire main body 2 is constituted of an elongated body which forms an elongated shape and has flexibility (i.e., is flexible). This wire main body 2 has a small-diameter portion 21, a tapered portion 22, and a large-diameter portion 23 which are sequentially disposed from a distal end toward a proximal end (i.e., the small-diameter portion 21 is distal to the tapered portion 22 and the tapered portion 22 is distal to the large-diameter portion 23”);
a coil member (4) surrounding and disposed along the distal end region of the elongate core member (see Figure 3 and [0078] – “In the embodiment depicted in FIG. 3, a distal portion of an inner coil 4 is fixed to a small-diameter portion 21 of a wire main body 2 through a fixation material 11 along with a distal portion of an outer coil 3”); and
an actuation member (5) secured to a distal end of the coil member and extending proximally therefrom along an exterior of the elongate core member to a location proximal of the coil member (see Figures 1-3 and [0065] – “The operation member 5 is a member which performs an operation of changing the interval p. The operation member 5 is constituted of a tube through which the wire main body 2 is inserted. The total length of the operation member 5 is shorter than that of the wire main body 2. The distal portion 51 of the operation member 5 is interlocked and fixed to the proximal portion of the inner coil 4”), the actuation member configured to shift the coil member between a first configuration (see Figure 1) and a compressed configuration (see Figure 2).
It is noted Nabeshima et al. does not specifically teach the actuation member is configured to be proximally retracted to apply compressive forces onto the coil member. However, Deckard et al. teaches the actuation member is configured to be proximally retracted to apply compressive forces onto the coil member (see Figures 1-2 and [0032] – “FIG. 2 shows the wire guide 102 of FIG. 1 with the spring 108 in a compressed state. When a user pulls the mandrel 104 in a proximal direction relative to the cannula 106, the distal tip 110 retracts towards the cannula 106 against the natural bias of the spring 108 and the spring 108 is compressed between the distal tip 110 and the cannula 106”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the guidewire of Nabeshima et al. to include the actuation member is configured to be proximally retracted to apply compressive forces onto the coil member, as disclosed in Deckard et al., so as to position the coil member in a loaded state near an occlusion to pass through and clear the occlusion (see Deckard et al.: [0052]).
Regarding claim 18, Nabeshima et al. discloses the coil member is formed of a plurality of coil windings extending around a longitudinal axis of the coil, the coil member having a gap between adjacent coil windings in the first configuration (see Figures 1 and 3 and [0047] – “These wire rods 41 have a densely wound portion and a roughly wound portion. That is, there is a portion of the inner coil 4 in which the wire rods 41 adjacent to each other in the longitudinal direction of the wire are closely contact to each other (i.e., densely wound), and a portion in which the wire rods 41 are separated from each other. In the separated portion, an interval p between the adjacent wire rods is variable (i.e., adjustable)”).
Regarding claim 19, Nabeshima et al. discloses the gap between adjacent coil windings is reduced on opposing sides of the longitudinal axis in the compressed configuration (see Figure 2 and [0048] – “As the interval p between adjacent wire rods 41 is decreased, the rigidity of the entirety of the inner coil 4 increases (i.e., the inner coil 4 becomes more rigid). As a result, the rigidity of the distal portion (which is a portion covered by the outer coil 3) of the guidewire 1 also increases (e.g., see FIG. 2 illustrating increased rigidity compared to FIG. 1)”).
Regarding claim 20, Nabeshima et al. discloses the actuation member extends to the proximal end region of the elongate core member (see Figures 1-3).
Claim(s) 4-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nabeshima et al. and Deckard et al., further in view of Wright et al. (US Publication No. 2009/0254001 A1).
Regarding claim 4, it is noted neither Nabeshima et al. nor Deckard et al. specifically teach the actuation member includes a wire. However, Wright et al. teaches the actuation member includes a wire (see [0053] – “As shown in FIGS. 2B and 2C, the tension wire 102 preferably is comprised of one or more wires which are wound together to form a coiled or cable type body, whereby the coils of the tension wire 102 are opposite to the coils of the outer body 106” and [0057] – “A preferred example of the tension wire 102 is a cable-braid wire which provides excellent tensional strength and stiffness and superior positional stability of the distal end of the guidewire 100 when under tension”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the guidewire of Nabeshima et al. and Deckard et al. to include the actuation member includes a wire, as disclosed in Wright et al., so as to provide excellent tensional strength and stiffness and superior positional stability of the distal end of the guidewire when under tension (see Wright et al.: [0057]).
Regarding claim 5, it is noted neither Nabeshima et al. nor Deckard et al. specifically teach the actuation member includes a stranded cable. However, Wright et al. teaches the actuation member includes a stranded cable (see [0053] – “As shown in FIGS. 2B and 2C, the tension wire 102 preferably is comprised of one or more wires which are wound together to form a coiled or cable type body, whereby the coils of the tension wire 102 are opposite to the coils of the outer body 106” and [0057] – “A preferred example of the tension wire 102 is a cable-braid wire which provides excellent tensional strength and stiffness and superior positional stability of the distal end of the guidewire 100 when under tension”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the guidewire of Nabeshima et al. and Deckard et al. to include the actuation member includes a stranded cable, as disclosed in Wright et al., so as to provide excellent tensional strength and stiffness and superior positional stability of the distal end of the guidewire when under tension (see Wright et al.: [0057]).
Claim(s) 6-7 and 10-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nabeshima et al. and Deckard et al., further in view of Palme, Jr. et al. (US Patent No. 8,740,815 B2).
Regarding claims 6 and 12, it is noted neither Nabeshima et al. nor Deckard et al. specifically teach the actuation member is secured to a distal end of the coil member. However, Palme, Jr. et al. teaches the actuation member is secured to a distal end of the coil member (see col. 15, lines 43-47 – “The guidewire 1100 has a filamentous or metal (not shown) actuating member 1130 attached 1122 to a distal end 1120 of a coil 1114 enabling the guidewire 1100 to deflect as shown in FIG. 6A upon proximal force being applied to the actuating member 1130”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the guidewire of Nabeshima et al. and Deckard et al. to include the actuation member is secured to a distal end of the coil member, as disclosed in Palme, Jr. et al., so as to transfer longitudinal force from the actuating member to the coil (see Palme, Jr. et al.: col. 3, lines 2-6).
Regarding claims 7 and 10, it is noted neither Nabeshima et al. nor Deckard et al. specifically teach a handle coupled to the actuation member. However, Palme, Jr. et al. teaches a handle (1134) coupled to the actuation member (see col. 7, lines 41-53 – “For the purpose of describing the actuation of all embodiments of the invention as described below, a generic handle 34, 134, 234, 334, 834, 1134, 1236, 1336 is used. The function of the handle 34, 134, 234, 334, 834, 1134, 1236, 1336 is to grip the outermost coated hollow shaft 24 or coated coil 102, 202, 302, 804, 1114, 1214, 1314 and move the actuating member 30, 130, 206, 306, 802, 1130, 1230, 1330. Using the handle 34, 134, 234, 334, 834, 1134, 1236, 1336 allows application of longitudinal force from the proximal end to the actuating member 30, 130, 206, 306, 802, 1130, 1230, 1330 and proximal force to the actuating member 1130, 1230, 1330, which causes the distal section 12, 104, 204, 304, 806, 1112, 1212, 1312 to deflect”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the guidewire of Nabeshima et al. and Deckard et al. to include a handle coupled to the actuation member, as disclosed in Palme, Jr. et al., so as to apply longitudinal force from the proximal end of the actuating member (see Palme, Jr. et al.: col. 7, lines 47-53).
Regarding claim 11, Palme, Jr. et al. teaches the actuation member includes a wire (see col. 15, lines 43-47 – “The guidewire 1100 has a filamentous or metal (not shown) actuating member 1130 attached 1122 to a distal end 1120 of a coil 1114 enabling the guidewire 1100 to deflect as shown in FIG. 6A upon proximal force being applied to the actuating member 1130”).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-14, 17, and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 and 17-20 of U.S. Patent No. 12,233,226 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the present claims are fully anticipated by the reference claims.
In particular, present claims 1-2, 9, 13, 17, and 20 are fully anticipated by reference claims 1 and 17.
Present claim 3 is fully anticipated by reference claims 7 and 20.
Present claims 4 and 11 are fully anticipated by reference claim 2.
Present claim 5 is fully anticipated by reference claim 3.
Present claims 6 and 12 are fully anticipated by reference claim 4.
Present claims 7 and 10 are fully anticipated by reference claims 5 and 18.
Present claims 8 and 14 are fully anticipated by reference claims 6 and 19.
Claims 15 and 18-19 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 17 of U.S. Patent No. 12,233,226 B2 in view of Nabeshima et al.
Regarding claim 15, the reference claims do not specifically teach the distal end region of the elongate core member includes at least one tapered region. However, Nabeshima et al. teaches the distal end region of the elongate core member includes at least one tapered region (see [0029] – “This wire main body 2 has a small-diameter portion 21, a tapered portion 22, and a large-diameter portion 23 which are sequentially disposed from a distal end toward a proximal end (i.e., the small-diameter portion 21 is distal to the tapered portion 22 and the tapered portion 22 is distal to the large-diameter portion 23)”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reference claims to include the distal end region of the elongate core member includes at least one tapered region, as disclosed in Nabeshima et al., so as to provide flexibility to the distal end of the core wire (see Nabeshima et al.: [0029]).
Regarding claim 18, the reference claims do not specifically teach the coil member is formed of a plurality of coil windings extending around a longitudinal axis of the coil, the coil member having a gap between adjacent coil windings in the first configuration. However, Nabeshima et al. teaches the coil member is formed of a plurality of coil windings extending around a longitudinal axis of the coil, the coil member having a gap between adjacent coil windings in the first configuration (see Figures 1 and 3 and [0047] – “These wire rods 41 have a densely wound portion and a roughly wound portion. That is, there is a portion of the inner coil 4 in which the wire rods 41 adjacent to each other in the longitudinal direction of the wire are closely contact to each other (i.e., densely wound), and a portion in which the wire rods 41 are separated from each other. In the separated portion, an interval p between the adjacent wire rods is variable (i.e., adjustable)”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reference claims to include the coil member is formed of a plurality of coil windings extending around a longitudinal axis of the coil, the coil member having a gap between adjacent coil windings in the first configuration, as disclosed in Nabeshima et al., so as to adjust the rigidity of the coil member and thus the guidewire (see Nabeshima et al.: [0048]).
Regarding claim 19, the reference claims do not specifically teach the gap between adjacent coil windings is reduced on opposing sides of the longitudinal axis in the compressed configuration. However, Nabeshima et al. teaches the gap between adjacent coil windings is reduced on opposing sides of the longitudinal axis in the compressed configuration (see Figure 2 and [0048] – “As the interval p between adjacent wire rods 41 is decreased, the rigidity of the entirety of the inner coil 4 increases (i.e., the inner coil 4 becomes more rigid). As a result, the rigidity of the distal portion (which is a portion covered by the outer coil 3) of the guidewire 1 also increases (e.g., see FIG. 2 illustrating increased rigidity compared to FIG. 1)”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reference claims to include the gap between adjacent coil windings is reduced on opposing sides of the longitudinal axis in the compressed configuration, as disclosed in Nabeshima et al., so as to adjust the rigidity of the coil member and thus the guidewire (see Nabeshima et al.: [0048]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEVIN B HENSON whose telephone number is (571)270-5340. The examiner can normally be reached M-F 7 AM ET - 5 PM ET.
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/DEVIN B HENSON/Primary Examiner, Art Unit 3791
Prosecution Insights