DETAILED ACTION
This office action is responsive to the amendment filed 10/13/2025. Claims 1, 3-5, 7-13, and 15-21 remain pending and under prosecution.
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 elements are interpreted under 112(f).
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.
Claim(s) 1, 3-5, 9, 10, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over JP 4955887 (hereafter referred to as “JP”) in view of Nelson III et al (US Pat No. 8480598 – cited in applicant), de Toledo (US Pat No. 5178158), Samson et al (US Pat No. 5827201 – cited by applicant), Radman et al (US Pub No. 20170055908), and McMahon (US Pat No. 6106485).
In regard to Claim 1, JP discloses a guidewire, comprising:
an elongated core wire 20 formed from a superelastic material, i.e. Nitinol (0013), best seen in Figure 1-2;
the elongated core wire having a proximal section 30 of uniform diameter (shown in Figure 3) and a tapered distal section 24 (0015) extending distally from a distal end of the proximal section, best seen in Figure 2 – “the coil wire is wrapped around the central portion of the core” (0015);
a wire – coil wire 30 – wound onto only the proximal section of the elongated core wire, best seen in Figure 2 – “the coil wire is wrapped around the central portion of the core” (0015);
a polymer cover 40 – lubricating coating 40 – disposed over the coil and the proximal section of the elongated core to attach the wire to the proximal section of the elongated core wire – “The material having lubricity for covering the coil wire 30 includes a hydrophobic material such as polytetrafluoroethylene and silicon, and a hydrophilic material such as a hydropath (HYDROPASS)” (0021), best seen in Figure 2 and 4-5;
no portion of the wire covers or contacts any portion of the elongated core wire distal of the tapered distal section, best seen in Figure 2,
the polymer cover extends only over the proximal section of the elongated core wire, i.e. only over coil wire 30.
However, JP does not disclose the wire comprising a first and second wire forming coils wound in opposite directions and the polymer cover disposed over both the first and second coils to attach the first and second coils to the proximal section of the elongated core wire.
Nelson III et al discloses a guidewire, comprising:
an elongated core wire 12, 14 formed from a superelastic material, best seen in Figure 7 (Col.3: 56-65);
the elongated core wire having a proximal section – defined as section 42 that includes the coils only and sections proximal thereof – and a tapered distal section, best seen in Figure 7;
a first wire 46 wound in a clockwise direction onto only the proximal section 42 and proximally of the elongated core wire to form a first coil, best seen in Figure 7 – the first wire is wound in a first direction (abst, Col.4: 29-31, 53-56);
a second wire 48 wound 206 in a counterclockwise direction (the second wire is wound in the opposite direction to the first wire – abst, Col.4: 29-31, 53-56) onto the first coil to form a second coil wherein no portion of the second coil contacts the elongated core wire, best seen in Figure 7 – wire 48 sits on top of wire 46 and therefore does not contact the elongated core wire, it is also noted that applicant does not disclose any importance toward the second wire not contacting the elongated core wire as this limitation is not discussed any portion of the disclosure; and
a polymer cover 50 disposed over the second coil and the proximal section of the elongated core wire to attach the first coil and the second coil to the proximal section of the elongated core wire, best seen in Figure 7 (Col.4: 58-60).
It is noted that while Nelson III et al disclose outer coil 48 is tapered in the distal direction, i.e. by shaving (Col.4: 39-49), at least a portion of outer coil 48 remains unshaved, i.e. not tapered, in said proximal portion, i.e. above element 46 in Figure 7. Said not tapered portions of the wound coils 46, 48 would result in an uneven profile due to the rounded profile of the coil in Nelson III et al, as is similarly suggested by the instant invention (0014 of publication).
Nelson III et al teach that having two wires wound as such has a specific advantage – “The two combined helical coils add stiffness and torque transmission to the guide wire without sacrificing tactile feedback” (abst).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify JP such that the wire comprising a first and second wire forming coils wound in opposite directions and the polymer cover disposed over both the first and second coils to attach the first and second coils to the proximal section of the elongated core wire as taught by Nelson III et al to provide advantages such as add stiffness and torque transmission to the guide wire without sacrificing tactile feedback.
However, JP as modified does not expressly disclose the first and second wires are multifilar wires, the polymer cover is attached to the first multifilar coil and the second multifilar coil.
De Toledo teach that it is well-known in the art to provide an analogous guidewire comprising a multifilar coil 21 as an effective configuration for its desired use (Col.4: 42-45).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify JP as modified by Nelson III et al such that the first and second wires are multifilar wires as taught by de Toledo as an effective configuration for its desired use, wherein in combination, no portion of the first multifilar coil and no portion of the second multifilar coil extends onto the distal section of the elongated core wire, as defined above.
When JP as modified by Nelson III et al is modified, the multifilar structure of de Toledo would result in the second coil and first coil of Nelson III et al being multifilar and with an uneven profile in the wound configuration, as elaborated above and as is similarly suggested by the instant invention (0014 of publication).
However, JP as modified do not expressly disclose the polymer cover contacts the first and second multifilar coil thereby providing an uneven outer surface on the polymer cover.
Samson et al teach that it is well-known in the art to provide an analogous guidewire including a polymer cover 184 that contacts coil 188, wherein the attaching of the polymer cover to the wire results in an uneven outer surface on the polymer cover, best seen in Figure 6B -- notice the bumpy or wavy surface of the polymer cover 184 – due to the uneven surface of the wire and the spaces adjacent each coil wind.
It is noted that Samson et al disclose at least one polymer cover layer (Col.5: 43-58; Col.8: 57-58; Col.11: 49-50), though typically two such as two-layer polymeric coating 184 of Figure 6B (Col.8: 19-25), either of which constitutes the polymer cover as broadly as has been claimed.
This uneven outer surface is also a result of the manner of attaching the polymer cover to the coil that includes shrink-wrapped, dipped, or sprayed onto the coil (Col.4: 41-48, 65-67; Col.11: 59-60; Col.13: 15-19; Col.14: 37-49), which would necessarily result in the polymer cover having a similar profile as the underlying coil. Furthermore, Samson et al teaches that the polymer cover is meant to be very thin, i.e. order of magnitude 10 micrometer thick (Col.11: 9-12; Col.14: 48-49; Col.15: 13-15; Col.15: 49-53). Thus, the manner of attaching the polymer cover 184 to coil 188 with the above thickness would result in the polymer cover of Samson et al contacting the coil thereby providing an uneven outer surface on the polymer cover.
Radman et al teach that it is well-known in the art to provide an analogous with a first coil 426 and a second coil 428 wound around each other such that the profile of the coils is uneven as a natural and expected result of the winding of two coils in a known manner, best seen in Figure 12 (0124).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify JP as modified such that the profile of the first and second coils wound together in the manner of Radman et al is uneven to provide the expected result of the coils of Nelson Ill et al wound in the manner above, such that when the polymer cover of JP or Nelson Ill et al contacts the coils as already taught by JP or Nelson Ill et al, the result would provide a polymer cover contacting the first multifilar coil and the second multifilar coil thereby providing an uneven outer surface on the polymer cover as taught by Samson et al which shows the nature of the contact of the polymer cover to the coil, as an effective configuration for said polymer cover when attached to the first and second coil of JP as modified by Nelson et al.
However, JP as modified is silent to the proximal section of the guidewire having a length in the range from 165 cm to 175 cm.
McMahon teaches an analogous guidewire (see McMahon: Abstract) wherein the proximal section of the guidewire has a length in the range from 165 cm to 175 cm (see McMahon: Column 4 lines 50-51 “proximal core section 12 may have a length of about 65 to about 280 cm, preferably about 150 to about 200 cm”). McMahon also teaches the guidewire entire length can be about 300 cm (Col.4: 43-45 – “The guidewires of the invention may have typical guidewire dimensions. Guidewire length may generally be about 90 to about 300 cm.”)
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to provide the guidewire as taught by JP as modified above, with the length of the proximal section as defined above in the range from 165 cm to 175 cm as taught by the guidewire of McMahon in order to design a guidewire in accordance with typical guidewire dimensions and to allow for the design of “longer guidewires” (see McMahon: Column 4, lines 43-47).
3. JP discloses the guidewire of claim 1, wherein the distal section 24 is a continuous taper, best seen in Figure 2.
4, 5. JP as modified by Nelson III et al, de Toledo, Samson et al, Radman et al, and McMahon
above disclose the invention above but do not expressly disclose the first multifilar coil and the second multifilar coil have transverse rectangular cross-sections.
Samson et al teach that it is well-known in the art to have first and second coils of an analogous guidewire with transverse rectangular cross-sections as an effective configuration for its use (Col.9: 54-57). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify JP as modified by Nelson III et al, de Toledo, Samson et al, Radman et al, and McMahon such that the first multifilar coil and the second multifilar coil have transverse rectangular cross-sections as taught by Samson et al as an equally as effectively shape for the coils of Nelson III et al for its desired use.
9. JP as modified in combination with Nelson III et al, de Toledo, Samson et al, Radman et al, and McMahon disclose the invention above but do not expressly disclose the material of the first multifilar coil or the second multifilar coil.
Samson et al teach that it is well-known in the art to provide an analogous guidewire with coils formed from a metallic material taken from the group of metallic materials including stainless steel, titanium, cobalt-chromium, tungsten, nitinol, platinum and silver, as an effective material for its use (Col.9: 63-Col.10: 7). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify JP as modified by Nelson III et al, de Toledo, Samson et al, Radman et al, and McMahon such that the material of the first multifilar coil or the second multifilar coil are formed from the material listed above as taught by Samson et al as an effective material for its use, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
10. JP discloses the guidewire of claim 1, wherein the superelastic material forming the elongated core wire is taken from the group of materials including NiTi, CuZnAl and Co—Cr—N (0013).
20. JP as modified by Nelson III et al and Radman et al discloses the guidewire of claim 1, wherein the first multifilar coil and the second multifilar coil together define an uneven profile, and the uneven outer surface on the polymer cover mimics the uneven profile as would be obvious in the combination.
Claim(s) 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over JP 4955887 (hereafter referred to as “JP”) in view of Nelson III et al (US Pat No. 8480598 – cited in applicant), de Toledo (US Pat No. 5178158), Samson et al (US Pat No. 5827201 – cited by applicant), Radman et al (US Pub No. 20170055908), and McMahon (US Pat No. 6106485) as applied to Claim 1 above, further in view of Crank (US Pub No. 20050049523).
JP in combination with Nelson III et al, de Toledo, Samson et al, Radman et al, and McMahon disclose the invention above but do not expressly disclose the first and second multifilar coils have a transverse I-beam shaped cross-section.
Crank teaches an analogous guidewire wherein one of the first multifilar coil or the second multifilar coil has a transverse I-beam shaped cross-section – “the cross-sectional shape of wire used to make the coil may be a circle, oval, rectangular, square, I-Beam, triangle, polygonal, and the like, or any suitable shape as further described below” (0037).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to provide the guidewire as taught by JP as modified by Nelson III et al, de Toledo, Samson et al, Radman et al, and McMahon with the cross-sectional I-beam shape of the coils of Crank to provide advantages as desired.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over JP 4955887 (hereafter referred to as “JP”) in view of Nelson III et al (US Pat No. 8480598 – cited in applicant), de Toledo (US Pat No. 5178158), Samson et al (US Pat No. 5827201 – cited by applicant), Radman et al (US Pub No. 20170055908), and McMahon (US Pat No. 6106485) as applied to Claim 1 above, further in view of Sharrow (US Pub No. 20070083132).
JP as modified by Nelson III et al, de Toledo, Samson et al, Radman et al, and McMahon disclose the invention above but do not expressly disclose the elongated core wire is formed from a hollow tubing.
Sharrow teach that it is well-known in the art to provide an analogous guidewire with an elongated core wire 1001 that can be either solid or hollow as an effective configuration for its desired use such as maximum “push-ability and torque-ability” (0057, 0061). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the elongated core wire of JP as modified by Nelson III et al, de Toledo, Samson et al, Radman et al, and McMahon such that the elongated core wire is formed from a hollow tubing as taught by Sharrow as an equally as effective configuration for its desired use such as for better pushability and torquability.
Claim(s) 12-13, 15-17, and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over JP 4955887 (hereafter referred to as “JP”) in view of Nelson III et al (US Pat No. 8480598 – cited in applicant), Samson et al (US Pat No. 5827201 – cited by applicant), Radman et al (US Pub No. 20170055908), and McMahon (US Pat No. 6106485).
In regard to Claim 12, JP discloses a guidewire, comprising:
an elongated core wire 20 formed from a superelastic material, i.e. Nitinol (0013), best seen in Figure 1-2;
the elongated core wire having a proximal section 30 of uniform diameter (shown in Figure 3) and a tapered distal section 24 (0015) extending distally from a distal end of the proximal section, best seen in Figure 2 – “the coil wire is wrapped around the central portion of the core” (0015);
a wire – coil wire 30 – wound onto only the proximal section of the elongated core wire, best seen in Figure 2 – “the coil wire is wrapped around the central portion of the core” (0015);
a polymer cover 40 – lubricating coating 40 – disposed over the coil and the proximal section of the elongated core to attach the wire to the proximal section of the elongated core wire – “The material having lubricity for covering the coil wire 30 includes a hydrophobic material such as polytetrafluoroethylene and silicon, and a hydrophilic material such as a hydropath (HYDROPASS)” (0021), best seen in Figure 2 and 4-5;
no portion of the wire covers or contacts any portion of the elongated core wire distal of the tapered distal section, best seen in Figure 2,
the polymer cover extends only over the proximal section of the elongated core wire, i.e. only over coil wire 30.
However, JP does not disclose the wire comprising a first and second wire forming coils wound in opposite directions and the polymer cover disposed over both the first and second coils to attach the first and second coils to the proximal section of the elongated core wire.
Nelson III et al teach a guidewire, comprising:
an elongated core wire 12, 14 formed from a superelastic material, best seen in Figure 7 (Col.3: 56-65);
the elongated core wire having a proximal section – defined as section 42 that includes the coils only and sections proximal thereof – and a tapered distal section, best seen in Figure 7;
a first wire 46 wound in a clockwise direction onto only the proximal section 42 and proximally of the elongated core wire to form a first coil, best seen in Figure 7 – the first wire is wound in a first direction (abst, Col.4: 29-31, 53-56);
a second wire 48 wound 206 in a counterclockwise direction (the second wire is wound in the opposite direction to the first wire – abst, Col.4: 29-31, 53-56) onto the first coil to form a second coil wherein no portion of the second coil contacts the elongated core wire, best seen in Figure 7 – wire 48 sits on top of wire 46 and therefore does not contact the elongated core wire, it is also noted that applicant does not disclose any importance toward the second wire not contacting the elongated core wire as this limitation is not discussed any portion of the disclosure; and
a polymer cover 50 attached to the first and second coil, as broadly as has been claimed, to attach the first coil and the second coil to the elongated core wire, best seen in Figure 7 (Col.4: 58-60).
It is noted that while Nelson III et al disclose outer coil 48 is tapered in the distal direction, i.e. by shaving (Col.4: 39-49), at least a portion of outer coil 48 remains unshaved, i.e. not tapered, in said proximal portion, i.e. above element 46 in Figure 7. Said not tapered portions of the wound coils 46, 48 would result in an uneven profile due to the rounded profile of the coil in Nelson III et al, as is similarly suggested by the instant invention (0014 of publication).
Nelson III et al teach that having two wires wound as such has a specific advantage – “The two combined helical coils add stiffness and torque transmission to the guide wire without sacrificing tactile feedback” (abst).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify JP such that the wire comprising a first and second wire forming coils wound in opposite directions and the polymer cover disposed over both the first and second coils to attach the first and second coils to the proximal section of the elongated core wire as taught by Nelson III et al to provide advantages such as add stiffness and torque transmission to the guide wire without sacrificing tactile feedback.
However, JP as modified do not expressly disclose the polymer cover contacts the first and second coil thereby providing an uneven outer surface on the polymer cover.
Samson et al teach that it is well-known in the art to provide an analogous guidewire including a polymer cover 184 that contacts coil 188, wherein the attaching of the polymer cover to the wire results in an uneven outer surface on the polymer cover, best seen in Figure 6B -- notice the bumpy or wavy surface of the polymer cover 184 – due to the uneven surface of the wire and the spaces adjacent each coil wind.
It is noted that Samson et al disclose at least one polymer cover layer (Col.5: 43-58; Col.8: 57-58; Col.11: 49-50), though typically two such as two-layer polymeric coating 184 of Figure 6B (Col.8: 19-25), either of which constitutes the polymer cover as broadly as has been claimed.
This uneven outer surface is also a result of the manner of attaching the polymer cover to the coil that includes shrink-wrapped, dipped, or sprayed onto the coil (Col.4: 41-48, 65-67; Col.11: 59-60; Col.13: 15-19; Col.14: 37-49), which would necessarily result in the polymer cover having a similar profile as the underlying coil. Furthermore, Samson et al teaches that the polymer cover is meant to be very thin, i.e. order of magnitude 10 micrometer thick (Col.11: 9-12; Col.14: 48-49; Col.15: 13-15; Col.15: 49-53). Thus, the manner of attaching the polymer cover 184 to coil 188 with the above thickness would result in the polymer cover of Samson et al contacting the coil thereby providing an uneven outer surface on the polymer cover.
Radman et al teach that it is well-known in the art to provide an analogous with a first coil 426 and a second coil 428 wound around each other such that the profile of the coils is uneven as a natural and expected result of the winding of two coils in a known manner, best seen in Figure 12 (0124).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify JP as modified such that the profile of the first and second coils wound together in the manner of Radman et al is uneven to provide the expected result of the coils of Nelson Ill et al wound in the manner above, such that when the polymer cover of JP or Nelson Ill et al contacts the coils as already taught by JP or Nelson Ill et al, the result would provide a polymer cover contacting the first coil and the second coil thereby providing an uneven outer surface on the polymer cover as taught by Samson et al which shows the nature of the contact of the polymer cover to the coil, as an effective configuration for said polymer cover when attached to the first and second coil of JP as modified by Nelson et al.
However, JP as modified is silent to the proximal section of the guidewire having a length in the range from 165 cm to 175 cm.
McMahon teaches an analogous guidewire (see McMahon: Abstract) wherein the proximal section of the guidewire has a length in the range from 165 cm to 175 cm (see McMahon: Column 4 lines 50-51 “proximal core section 12 may have a length of about 65 to about 280 cm, preferably about 150 to about 200 cm”). McMahon also teaches the guidewire entire length can be about 300 cm (Col.4: 43-45 – “The guidewires of the invention may have typical guidewire dimensions. Guidewire length may generally be about 90 to about 300 cm.”)
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to provide the guidewire as taught by JP as modified above, with the length of the proximal section as defined above in the range from 165 cm to 175 cm as taught by the guidewire of McMahon in order to design a guidewire in accordance with typical guidewire dimensions and to allow for the design of “longer guidewires” (see McMahon: Column 4, lines 43-47).
15. JP discloses the guidewire of claim 1, wherein the distal section 24 is a continuous taper, best seen in Figure 2.
13, 16, 17. JP as modified by Nelson III et al, Samson et al, Radman et al, and McMahon above disclose the invention above but do not expressly disclose the first coil and the second coil have transverse rectangular cross-sections.
Samson et al teach that it is well-known in the art to have first and second coils of an analogous guidewire with transverse rectangular cross-sections as an effective configuration for its use (Col.9: 54-57). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify JP as modified by Nelson III et al, Samson et al, Radman et al, and McMahon such that the first coil and the second coil have transverse rectangular cross-sections as taught by Samson et al as an equally as effectively shape for the coils of JP as modified by Nelson III et al for its desired use.
21. JP as modified by Nelson III et al and Radman et al discloses the guidewire of claim 12, wherein the first coil and the second coil together define an uneven profile, and the uneven outer surface on the polymer cover mimics the uneven profile as would be obvious in the combination.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over JP 4955887 (hereafter referred to as “JP”) in view of Nelson III et al (US Pat No. 8480598 – cited in applicant), Samson et al (US Pat No. 5827201 – cited by applicant), Radman et al (US Pub No. 20170055908), and McMahon (US Pat No. 6106485) as applied to Claim 12 above, further in view of Crank (US Pub No. 20050049523).
JP in combination with Nelson III et al, de Toledo, Samson et al, Radman et al, and McMahon disclose the invention above but do not expressly disclose the first and second wires have a transverse I-beam shaped cross-section.
Crank teaches an analogous guidewire wherein one of the first wire or the second wire has a transverse I-beam shaped cross-section – “the cross-sectional shape of wire used to make the coil may be a circle, oval, rectangular, square, I-Beam, triangle, polygonal, and the like, or any suitable shape as further described below” (0037).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to provide the guidewire as taught by JP as modified by Nelson III et al, Samson et al, Radman et al, and McMahon with the cross-sectional I-beam shape of the coils of Crank to provide advantages as desired.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over JP (hereafter referred to as “JP”) in view of Nelson III et al (US Pat No. 8480598 – cited in applicant), de Toledo (US Pat No. 5178158), Samson et al (US Pat No. 5827201 – cited by applicant), Radman et al (US Pub No. 20170055908), McMahon (US Pat No. 6106485), and Sharrow (US Pub No. 20070083132).
JP discloses a guidewire, comprising:
an elongated core wire 20 formed from a superelastic material, i.e. Nitinol (0013), best seen in Figure 1-2;
the elongated core wire having a proximal section 30 of uniform diameter (shown in Figure 3) and a tapered distal section 24 (0015) extending distally from a distal end of the proximal section, best seen in Figure 2 – “the coil wire is wrapped around the central portion of the core” (0015);
a wire – coil wire 30 – wound onto only the proximal section of the elongated core wire, best seen in Figure 2 – “the coil wire is wrapped around the central portion of the core” (0015);
a polymer cover 40 – lubricating coating 40 – disposed over the coil and the proximal section of the elongated core to attach the wire to the proximal section of the elongated core wire – “The material having lubricity for covering the coil wire 30 includes a hydrophobic material such as polytetrafluoroethylene and silicon, and a hydrophilic material such as a hydropath (HYDROPASS)” (0021), best seen in Figure 2 and 4-5;
no portion of the wire covers or contacts any portion of the elongated core wire distal of the tapered distal section, best seen in Figure 2,
the polymer cover extends only over the proximal section of the elongated core wire, i.e. only over coil wire 30.
However, JP does not disclose the wire comprising a first and second wire forming coils wound in opposite directions and the polymer cover disposed over both the first and second coils to attach the first and second coils to the proximal section of the elongated core wire.
Nelson III et al discloses a guidewire, comprising:
an elongated core wire 12, 14 formed from a superelastic material, best seen in Figure 7 (Col.3: 56-65);
the elongated core wire having a proximal section – defined as section 42 that includes the coils only and sections proximal thereof – and a tapered distal section, best seen in Figure 7;
a first wire 46 wound in a clockwise direction onto only the proximal section 42 and proximally of the elongated core wire to form a first coil, best seen in Figure 7 – the first wire is wound in a first direction (abst, Col.4: 29-31, 53-56);
a second wire 48 wound 206 in a counterclockwise direction (the second wire is wound in the opposite direction to the first wire – abst, Col.4: 29-31, 53-56) onto the first coil to form a second coil wherein no portion of the second coil contacts the elongated core wire, best seen in Figure 7 – wire 48 sits on top of wire 46 and therefore does not contact the elongated core wire, it is also noted that applicant does not disclose any importance toward the second wire not contacting the elongated core wire as this limitation is not discussed any portion of the disclosure; and
a polymer cover 50 attached to the first and second coil, as broadly as has been claimed, to attach the first coil and the second coil to the elongated core wire, best seen in Figure 7 (Col.4: 58-60).
It is noted that while Nelson III et al disclose outer coil 48 is tapered in the distal direction, i.e. by shaving (Col.4: 39-49), at least a portion of outer coil 48 remains unshaved, i.e. not tapered, in said proximal portion, i.e. above element 46 in Figure 7. Said not tapered portions of the wound coils 46, 48 would result in an uneven profile due to the rounded profile of the coil in Nelson III et al, as is similarly suggested by the instant invention (0014 of publication).
Nelson III et al teach that having two wires wound as such has a specific advantage – “The two combined helical coils add stiffness and torque transmission to the guide wire without sacrificing tactile feedback” (abst).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify JP such that the wire comprising a first and second wire forming coils wound in opposite directions and the polymer cover disposed over both the first and second coils to attach the first and second coils to the proximal section of the elongated core wire as taught by Nelson III et al to provide advantages such as add stiffness and torque transmission to the guide wire without sacrificing tactile feedback.
However, JP as modified does not expressly disclose the first and second wires are multifilar wires, the polymer cover is attached to the first multifilar coil and the second multifilar coil.
De Toledo teach that it is well-known in the art to provide an analogous guidewire comprising a multifilar coil 21 as an effective configuration for its desired use (Col.4: 42-45).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify JP as modified by Nelson III et al such that the first and second wires are multifilar wires as taught by de Toledo as an effective configuration for its desired use, wherein in combination, no portion of the first multifilar coil and no portion of the second multifilar coil extends onto the distal section of the elongated core wire, as defined above.
When JP as modified by Nelson III et al is modified, the multifilar structure of de Toledo would result in the second coil and first coil of Nelson III et al being multifilar and with an uneven profile in the wound configuration, as elaborated above and as is similarly suggested by the instant invention (0014 of publication).
However, JP as modified do not expressly disclose the polymer cover contacts the first and second multifilar coil thereby providing an uneven outer surface on the polymer cover.
Samson et al teach that it is well-known in the art to provide an analogous guidewire including a polymer cover 184 that contacts coil 188, wherein the attaching of the polymer cover to the wire results in an uneven outer surface on the polymer cover, best seen in Figure 6B -- notice the bumpy or wavy surface of the polymer cover 184 – due to the uneven surface of the wire and the spaces adjacent each coil wind.
It is noted that Samson et al disclose at least one polymer cover layer (Col.5: 43-58; Col.8: 57-58; Col.11: 49-50), though typically two such as two-layer polymeric coating 184 of Figure 6B (Col.8: 19-25), either of which constitutes the polymer cover as broadly as has been claimed.
This uneven outer surface is also a result of the manner of attaching the polymer cover to the coil that includes shrink-wrapped, dipped, or sprayed onto the coil (Col.4: 41-48, 65-67; Col.11: 59-60; Col.13: 15-19; Col.14: 37-49), which would necessarily result in the polymer cover having a similar profile as the underlying coil. Furthermore, Samson et al teaches that the polymer cover is meant to be very thin, i.e. order of magnitude 10 micrometer thick (Col.11: 9-12; Col.14: 48-49; Col.15: 13-15; Col.15: 49-53). Thus, the manner of attaching the polymer cover 184 to coil 188 with the above thickness would result in the polymer cover of Samson et al contacting the coil thereby providing an uneven outer surface on the polymer cover.
Radman et al teach that it is well-known in the art to provide an analogous with a first coil 426 and a second coil 428 wound around each other such that the profile of the coils is uneven as a natural and expected result of the winding of two coils in a known manner, best seen in Figure 12 (0124).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify JP as modified such that the profile of the first and second coils wound together in the manner of Radman et al is uneven to provide the expected result of the coils of Nelson Ill et al wound in the manner above, such that when the polymer cover of JP or Nelson Ill et al contacts the coils as already taught by JP or Nelson Ill et al, the result would provide a polymer cover contacting the first multifilar coil and the second multifilar coil thereby providing an uneven outer surface on the polymer cover as taught by Samson et al which shows the nature of the contact of the polymer cover to the coil, as an effective configuration for said polymer cover when attached to the first and second coil of JP as modified by Nelson et al.
However, JP as modified is silent to the proximal section of the guidewire having a length in the range from 165 cm to 175 cm.
McMahon teaches an analogous guidewire (see McMahon: Abstract) wherein the proximal section of the guidewire has a length in the range from 165 cm to 175 cm (see McMahon: Column 4 lines 50-51 “proximal core section 12 may have a length of about 65 to about 280 cm, preferably about 150 to about 200 cm”). McMahon also teaches the guidewire entire length can be about 300 cm (Col.4: 43-45 – “The guidewires of the invention may have typical guidewire dimensions. Guidewire length may generally be about 90 to about 300 cm.”)
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to provide the guidewire as taught by JP as modified above, with the length of the proximal section as defined above in the range from 165 cm to 175 cm as taught by the guidewire of McMahon in order to design a guidewire in accordance with typical guidewire dimensions and to allow for the design of “longer guidewires” (see McMahon: Column 4, lines 43-47).
However, JP as modified do not expressly disclose the elongated core wire is formed from a hollow tubing.
Sharrow teach that it is well-known in the art to provide an analogous guidewire with an elongated core wire 1001 that can be either solid or hollow as an effective configuration for its desired use such as maximum “push-ability and torque-ability” (0057, 0061).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the elongated core wire of JP as modified such that the elongated core wire is formed from a hollow tubing as taught by Sharrow as an equally as effective configuration for its desired use such as for better pushability and torquability.
Response to Arguments
Applicant’s arguments with respect to claim(s) above with respect to the new amendments have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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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/H.Q.N/Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791