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 .
Election/Restrictions
Newly submitted Claims 24-25 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j). In the instant case, the inventions as claimed 1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect (Claim 24 recites “a portion adjacent to the distal end portion of the first core shaft is entirely joined”; Claim 25 recites “between the distal end portion and the proximal end-side portion of the first core shaft, a portion whose nanoindentation hardness is greater than that of the distal end portion and less than that of the proximal end-side portion is provided, and a proximal end portion of the second core shaft is positioned more distal than the portion”; these are both materially different designs than the originally claimed invention); (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
The new claims would require different subclass and keyword searches.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, Claims 24-25 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Response to Arguments
Applicant’s arguments, see page 9, filed 11/06/2025, with respect to the rejection of Claims 1-18 under 35 U.S.C. 112(b) have been fully considered and are persuasive. The rejection of Claims 1-18 under 35 U.S.C. 112(b) has been withdrawn.
Applicant's arguments filed 11/06/2025 have been fully considered but they are not persuasive.
Regarding the rejection of Claim 1 over Henderson, the applicant has argued “Since Henderson describes 'In other embodiments, molding the distal portion of the core wire 300 may include grinding, cutting and or cutting," it is understood that even when the core wire 300 is made of a superelastic material, grinding or cutting results in a similar breaking elongation. Moreover, when both the core wire 300and the shaping ribbon 350 are made of stainless steel, if a flattened section is formed by pressing, the amount of breaking elongation of the flattened section becomes smaller, so the difference in breaking elongation amount from the second core shaft becomes even larger”. Henderson clearly teaches molding the distal portion of core wire 300 by pressing (11:5-7) wherein the core wire is made of Ni-Ti (10:33-11:1), which corresponds to the applicant’s specification (page 10) and the broadest reasonable interpretation of the claim. A specific situation of the wire being made of stainless steel and formed via grinding or cutting is not relevant to the current rejection.
Regarding the Examiner’s assertion that Henderson discloses Feature A: “compared to the proximal portions of the first core shaft, the breaking elongation against a tensile load is smaller”, the applicant has argued “Further, the "cold forming” flattened sections on a superelastic core wire in Henderson would not inherently result in a lesser breaking elongation as alleged on page 5 of the Office Action. Henderson's sole motivation for forming flattened sections is to solve a geometric problem-preventing a shaping ribbon from kinking at the joint. The very purpose of using a superelastic material like "nickel titanium or nitinol" for Henderson's core wire (300) is to leverage its superelastic properties to allow the guidewire to navigate tortuous anatomy without kinking. A person of ordinary skill in the art, following Henderson's teachings, would be motivated to preserve the superelastic characteristics of the core wire.” However, a claim containing a ‘recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus’ if the prior art apparatus has all the structural limitations of the claim. See MPEP 2114(II). “Absent a clear disclaimer of particular subject matter, the fact that the inventor anticipated that the invention may be used in a particular manner does not limit the scope to that narrow context.” MPEP 2111.01. For a reference to teach away from a modification (destroying the superelastic characteristics of the core wire), it has to explicitly disparage the teaching specifically.
Regarding the Examiner’s assertion that Satou at least suggests Feature B: “compared to the proximal portions of the first core shaft, the amount of breaking elongation against a tensile load is closer to amount of a breaking elongation attributed to a tensile load on the second core shaft compared to the portion on the proximal end side with respect to the distal end portion”, the applicant has argued “paragraph [0058] of Satou, which is the basis for the above determination, merely states that because the shaping ribbon 3 is fixed to the wire main body 2 at two positions, the distal end and the proximal end of the overlapping portion 32, the mechanical characteristics of the overlapping portion 32 are the combined characteristics of the wire main body 2 and the shaping ribbon 3. In other words, paragraph [0058] of Satou only indicates the characteristics of the entire overlapping portion 32 (dashed circle in the FIG.1 of Satou reproduced and annotated below) where the wire main body 2 and the shaping ribbon 3 overlap, and does not describe the characteristics of "only the distal end portion of the wire main body 2.” Satou teaches managing stress with an external coil, not modifying the internal properties of the core wire”. However, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). One of ordinary skill in the art could have, before the effective filing date of the claimed invention, seen the advantages of applying the characteristics of the overlapping portion 32 to the apparatus of Henderson. See further details in the rejection below.
However, due to further amendments, a new ground(s) of rejection is made in view of Henderson, Satou, and Purtzer.
Claim Objections
Claim 1 is objected to because of the following informalities:
In Claim 1, “an amount of the breaking elongation attributed to the tensile load on the distal end portion of the first core shaft is closer to an amount of a breaking elongation attributed to a tensile load on the second core shaft, compared to the portion on the proximal end side with respect to the distal end portion” should read “an amount of the breaking elongation attributed to the tensile load on the distal end portion of the first core shaft is closer to an amount of a breaking elongation attributed to a tensile load on the second core shaft, compared to the portion on the proximal end side of the first core shaft with respect to the distal end portion”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites “a strain amount at the distal end portion of the first core shaft is 60% or less compared to that of other portions of the first core shaft”. The applicant asserts this limitation is disclosed in [0055]-[0057] of the As-filed Specification. Fig. 9 shows strain amounts of four samples S1-S4, and [0055] recites “The strain amount of the sample S3 is about 60% of the sample S1, and the strain amount of the sample S4 is about 50% of the sample S1”. However, this is comparing the strain amount of samples to each other, not to different parts of the same core shaft, and there is only a disclosure of a sample being 60% strain amount and 50% strain amount of another sample—no range of “or less” disclosed. [0057] recites “It is understood that the nanoindentation hardness of the distal end portion 11 of the first core shaft 10 may be 1.1 times or higher than the nanoindentation hardness of the portions (first reduced diameter portion 12, first large diameter portion 15, second reduced diameter portion 16, and second large diameter portion 17) on the proximal end side with respect to the distal end portion 11”. However, this does not teach that a strain amount at the distal end portion of the first core shaft is 60% or less compared to that of other portions of the first core shaft.
Claims 2-18 are rejected by virtue of dependence on Claim 1.
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.
Claims 1, 3, 13-14, 17-18 and 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Henderson et al (WO 2016012902 A1, cited in applicant’s IDS, hereinafter Henderson) in view of Satou et al (US 20110015618 A1, cited in applicant’s IDS, hereinafter Satou) and Purtzer (US 20130006149 A1, hereinafter Purtzer).
Regarding Claim 1, Henderson discloses a guide wire (Element 100, Fig. 1) comprising:
a first core shaft (Element 300, Fig. 3; “Figs. 3-7c illustrate aspects of the distal portion 104 of the intra vascular device 100 according to an exemplary embodiment. Fig. 3 illustrates various components of the distal portion 104, including a core wire 300 and a shaping ribbon 350…”, 9:18-20) made of a superelastic material (“The core wire 300 can be formed of a flexible and/or elastic material, including metals or metal alloys such as nickel titanium…”, 10:33-11:1; this corresponds to the applicant’s specification on page 10, which recites “The first core shaft 10 is made of a superelastic material, e.g., a NiTi (nickel-titanium) alloy, or an alloy of Ni Ti and another metal”); and
a second core shaft (Element 350) made of a material more plastically deformable than the first core shaft (“The shaping ribbon 350 can be formed a shapeable material including, for example, a metal or metal alloy such as stainless steel and/or other suitable materials”, 12:28-29; this corresponds to the applicant’s specification on page 15, which recites “The second core shaft 30 is made of a material that is more plastically deformable than the first core shaft 10, e.g., a stainless steel alloy such as SUS304 and SUS316. The second core shaft 30 is also referred to as "ribbon"…”) and joined to a distal end portion of the first core shaft (See Fig. 3; “The shaping ribbon 350 can be coupled to the core wire 300 along at least a portion of one or more of the flattened sections 304, 306”, 10:4-5), wherein
on the distal end portion (Elements 304 and/or 306) to which the second core shaft is joined in the first core shaft, a breaking elongation attributed to a tensile load is lesser compared to a portion on a proximal end side of the first core shaft (Element 302, Fig. 3) with respect to the distal end portion (“In some embodiments, shaping the distal portion of the core wire 300 can include cold forming the at least two flattened sections 304, 306, such as by pressing the distal portion with suitable dies”, 11:5-7; cold forming the flattened sections also makes the metal alloys stronger, harder, and less plastic, and therefore a breaking elongation attributed to a tensile load would be lesser than compared to a proximal end side that has not been cold-formed).
Henderson discloses the claimed invention except for expressly disclosing wherein an amount of the breaking elongation attributed to the tensile load on the distal end portion of the first core shaft is closer to an amount of a breaking elongation attributed to a tensile load on the second core shaft, compared to the portion on the proximal end side with respect to the distal end portion, and
a strain amount at the distal end portion of the first core shaft is 60% or less compared to that of other portions of the first core shaft.
However, Satou, which also discloses a guidewire (Abstract), teaches wherein an amount of the breaking elongation attributed to the tensile load on the distal end portion of the first core shaft is closer to an amount of a breaking elongation attributed to a tensile load on the second core shaft, compared to the portion on the proximal end side with respect to the distal end portion (“As described above, the shaping ribbon 3 is secured to the wire main body 2 only at the two positions of the distal end and proximal end, not at the overall overlapping portion 32. Therefore, the mechanical characteristics of the overlapping portion 32 combine both the characteristic of the wire main body 2 and the characteristic of the shaping ribbon 3. Thus, if the wire main body 2 uses a wire material exhibiting superelasticity such as a Ni--Ti alloy, the mechanical characteristics of the overlapping portion 32 combine both the reshaping performance and superelasticity of the shaping ribbon 3. The guide wire 1 described above has such a mechanical characteristic as to gradually increase shaping performance as it goes toward the distal end direction, whereas to gradually increase superelasticity as it goes toward the proximal end direction”, [0058]; the disclosed superelasticity corresponds to the properties in the applicant’s description of this claim limitation in [0040] of the specification). 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 guide wire of Henderson as taught by Satou, such that an amount of the breaking elongation attributed to the tensile load on the distal end portion of the first core shaft is closer to an amount of a breaking elongation attributed to a tensile load on the second core shaft, compared to the portion on the proximal end side with respect to the distal end portion, because such a guide wire 1 can easily be inserted into a blood vessel and is superior in branch selectability (superior in operability) at a branch portion of the blood vessel (Satou, [0058]).
Purtzer, which also discloses a guide wire (Abstract), teaches a strain amount at the distal end portion of the first core shaft (Element 108, Fig. 1A; “Guide wire devices include an elongate shaft member having a shapeable distal end section that is formed from a linear pseudoelastic nickel-titanium (Ni--Ti) alloy that has linear pseudoelastic behavior”, Abstract) is 60% or less compared to that of other portions of the first core shaft (“The Ni--Ti alloy portion 104 may also include a superelastic portion proximal to the shapeable distal end section 108 to facilitate the advancing of the guide wire in a body lumen”, [0039]; See Fig. 2, where at a given stress, the strain amount of linear pseudoelastic 218/220 is less than non-linear pseudoelastic (i.e., superelastic) Ni--Ti alloy 200; this strain amount could be 60% or less than the non-linear pseudoelastic (i.e., superelastic) Ni--Ti alloy 200 based on routine optimization of the degree of cold work of the linear pseudoelastic distal tip disclosed in Fig. 4 and [0059]-[0060]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify Henderson in view of Purtzer such that a strain amount at the distal end portion of the first core shaft is 60% or less compared to that of other portions of the first core shaft, as taught by Purtzer, because a distal tip made from a linear pseudoelastic material is durable and shapable, as taught by Purtzer ([0008]).
Regarding Claim 3, modified Henderson discloses the guide wire according to claim 1, wherein a nanoindentation hardness on the distal end portion of the first core shaft is higher compared to the portion on the proximal end side with respect to the distal end portion (“In some embodiments, shaping the distal portion of the core wire 300 can include cold forming the at least two flattened sections 304, 306, such as by pressing the distal portion with suitable dies”, 11:5-7; cold forming the flattened sections also makes the metal alloys stronger, harder, and less plastic, and therefore a nanoindentation hardness of the cold-formed distal portion would be higher than compared to a proximal end side that has not been cold-formed).
Regarding Claim 13, modified Henderson discloses the guide wire according to claim 3, wherein the first core shaft has a reduced diameter portion (Element 302, Fig. 3) whose outer diameter decreases from the proximal end side toward a distal end side (See Fig. 6a), and the distal end portion of the first core shaft (Element 304) is connected to a distal end of the reduced diameter portion (See Fig. 6a; Elements 304 and 302 are connected via element 312).
Regarding Claim 14, modified Henderson discloses the guide wire according to claim 13, further comprising: a portion having a nanoindentation hardness that increases from the proximal end side toward a distal end side on the distal end portion of the reduced diameter portion (“In some embodiments, shaping the distal portion of the core wire 300 can include cold forming the at least two flattened sections 304, 306, such as by pressing the distal portion with suitable dies”, 11:5-7; cold forming the flattened sections also makes the metal alloys stronger, harder, and less plastic than the proximal end side, and therefore a portion having a nanoindentation hardness that increases from the proximal end side toward the distal end side on the distal end portion of the reduced diameter portion exists).
Regarding Claim 17, modified Henderson discloses the guide wire according to claim 1, wherein the first core shaft has a reduced diameter portion (Element 302, Fig. 3) whose outer diameter decreases from the proximal end side toward a distal end side (See Fig. 6a), and the distal end portion of the first core shaft (Element 304) is connected to a distal end of the reduced diameter portion (See Fig. 6a; Elements 304 and 302 are connected via element 312).
Regarding Claim 18, modified Henderson discloses the guide wire according to claim 17, further comprising: a portion having a nanoindentation hardness that increases from the proximal end side toward the distal end side on the distal end portion of the reduced diameter portion (“In some embodiments, shaping the distal portion of the core wire 300 can include cold forming the at least two flattened sections 304, 306, such as by pressing the distal portion with suitable dies”, 11:5-7; cold forming the flattened sections also makes the metal alloys stronger, harder, and less plastic than the proximal end side, and therefore a portion having a nanoindentation hardness that increases from the proximal end side toward the distal end side on the distal end portion of the reduced diameter portion exists).
Regarding Claim 20, modified Henderson discloses the guide wire according to claim 1. Modified Henderson discloses the claimed invention except for expressly disclosing wherein on the distal end portion of the first core shaft, a plateau region of the superelastic material is eliminated. However, Purtzer teaches wherein on the distal end portion of the first core shaft, a plateau region of the superelastic material is eliminated (“Non-linear pseudoelasticity, in its idealized state, exhibits a relatively flat loading plateau in which a large amount of recoverable strain is possible with very little increase in stress… Linear pseudoelasticity exhibits no such flat plateau”, [0007]; the distal tip is made of linear pseudoelastic plastic (Abstract); therefore, this plateau region would be eliminated). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify Henderson in view of Purtzer because a distal tip made from a linear pseudoelastic material is durable and shapable, as taught by Purtzer ([0008]).
Regarding Claim 21, modified Henderson discloses the guide wire according to claim 17. Modified Henderson discloses the claimed invention except for expressly disclosing wherein the second core shaft does not overlap the reduced diameter portion of the first core shaft. However, Satou teaches wherein the second core shaft (Element 31 which is part of element 3, Fig. 2) does not overlap the reduced diameter portion of the first core shaft (See Fig. 2; “Incidentally, of the shaping ribbon 3, a portion located on the distal end side and projecting toward the distal end from the distal end of the wire main body 2 is called "the extending portion 31" and a portion located on the proximal end side and overlapping the wire main body 2 is called "the overlapping portion 32."”, [0056]; therefore, the extending portion 31 of the second core shaft 3 does not overlap the reduced diameter portion 24 of the first core shaft 2). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify Henderson with Satou, because all of the claimed elements were known in the prior art before the effective filing date of the claimed invention, and one with ordinary skill in the art could have combined all the claimed elements by known methods, and the result would have been obvious to one of ordinary skill in the art.
Claims 4 and 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over modified Henderson.
Regarding Claim 4, modified Henderson discloses the guide wire according to claim 3. Modified Henderson discloses the claimed invention except for expressly disclosing wherein the nanoindentation hardness on the distal end portion of the first core shaft is not less than 1.1 times the nanoindentation hardness of the portion on the proximal end side with respect to the distal end portion. However, Henderson does teach wherein the nanoindentation hardness on the distal end portion of the first core shaft is not less than 1 times the nanoindentation hardness of the portion on the proximal end side with respect to the distal end portion (“In some embodiments, shaping the distal portion of the core wire 300 can include cold forming the at least two flattened sections 304, 306, such as by pressing the distal portion with suitable dies”, 11:5-7; cold forming the flattened sections also makes the metal alloys stronger, harder, and less plastic, and therefore a nanoindentation hardness on the distal end portion of the first core shaft is not less than 1 times the nanoindentation hardness of the portion on the proximal end side with respect to the distal end portion). As cold forming metal guide wires to varying amounts of hardness is well known in the prior art, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to cold form the flattened sections such that the nanoindentation hardness on the distal end portion of the first core shaft is not less than 1.1 times the nanoindentation hardness of the portion on the proximal end side with respect to the distal end portion as a matter of routine optimization within prior art conditions or through routine experimentation.
Regarding Claim 8, modified Henderson discloses the guide wire according to claim 4, wherein the first core shaft has a reduced diameter portion (Element 302, Fig. 3) whose outer diameter decreases from the proximal end side toward a distal end side (See Fig. 6a), and the distal end portion of the first core shaft (Element 304) is connected to a distal end of the reduced diameter portion (See Fig. 6a; Elements 304 and 302 are connected via element 312).
Regarding Claim 9, modified Henderson discloses the guide wire according to claim 8, further comprising: a portion having a nanoindentation hardness that gradually increases from the proximal end side toward the distal end side on the distal end portion of the reduced diameter portion (“In some embodiments, shaping the distal portion of the core wire 300 can include cold forming the at least two flattened sections 304, 306, such as by pressing the distal portion with suitable dies”, 11:5-7; cold forming the flattened sections also makes the metal alloys stronger, harder, and less plastic than the proximal end side, and therefore a portion having a nanoindentation hardness that increases from the proximal end side toward the distal end side on the distal end portion of the reduced diameter portion exists; the rejection of this claim under 35 U.S.C. § 112(b) is being used in the interpretation of this claim).
Claims 5-7 and 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Henderson in view of Satou and Purtzer, and further in view of Endo (US 20190097341 A1, hereinafter Endo).
Regarding Claim 5, modified Henderson discloses the guide wire according to claim 4. Modified Henderson discloses the claimed invention except for expressly disclosing wherein the nanoindentation hardness on the distal end portion of the first core shaft is 4500 N/mm2 or higher. However, Endo, which also discloses a nickel alloy (Abstract), teaches (“In still another embodiment of the Ni-plated copper or copper alloy material, an ultrafine indentation hardness of the surface of the Ni plating is 4500 N/mm2 or more”, [0010]). 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 guide wire of Henderson wherein the nanoindentation hardness on the distal end portion of the first core shaft is 4500 N/mm2 or higher as a matter of routine optimization within prior art conditions or through routine experimentation.
Regarding Claim 6, modified Henderson discloses the guide wire according to claim 5, wherein the first core shaft has a reduced diameter portion (Element 302, Fig. 3) whose outer diameter decreases from the proximal end side toward a distal end side (See Fig. 6a), and the distal end portion of the first core shaft (Element 304) is connected to a distal end of the reduced diameter portion (See Fig. 6a; Elements 304 and 302 are connected via element 312).
Regarding Claim 7, modified Henderson discloses the guide wire according to claim 6, further comprising: a portion having a nanoindentation hardness that increases from the proximal end side toward the distal end side on the distal end portion of the reduced diameter portion (“In some embodiments, shaping the distal portion of the core wire 300 can include cold forming the at least two flattened sections 304, 306, such as by pressing the distal portion with suitable dies”, 11:5-7; cold forming the flattened sections also makes the metal alloys stronger, harder, and less plastic than the proximal end side, and therefore a portion having a nanoindentation hardness that increases from the proximal end side toward the distal end side on the distal end portion of the reduced diameter portion exists).
Regarding Claim 10, modified Henderson discloses the guide wire according to claim 3. Modified Henderson discloses the claimed invention except for expressly disclosing wherein the nanoindentation hardness on the distal end portion of the first core shaft is 4500 N/mm2 or higher. However, Endo, which also discloses a nickel alloy (Abstract), teaches (“In still another embodiment of the Ni-plated copper or copper alloy material, an ultrafine indentation hardness of the surface of the Ni plating is 4500 N/mm2 or more”, [0010]). 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 guide wire of Henderson wherein the nanoindentation hardness on the distal end portion of the first core shaft is 4500 N/mm2 or higher as a matter of routine optimization within prior art conditions or through routine experimentation.
Regarding Claim 11, modified Henderson discloses the guide wire according to claim 10, wherein the first core shaft has a reduced diameter portion (Element 302, Fig. 3) whose outer diameter decreases from the proximal end side toward a distal end side (See Fig. 6a), and the distal end portion of the first core shaft (Element 304) is connected to a distal end of the reduced diameter portion (See Fig. 6a; Elements 304 and 302 are connected via element 312).
Regarding Claim 12, modified Henderson discloses the guide wire according to claim 11, further comprising: a portion having a nanoindentation hardness that increases from the proximal end side toward a distal end side on the distal end portion of the reduced diameter portion (“In some embodiments, shaping the distal portion of the core wire 300 can include cold forming the at least two flattened sections 304, 306, such as by pressing the distal portion with suitable dies”, 11:5-7; cold forming the flattened sections also makes the metal alloys stronger, harder, and less plastic than the proximal end side, and therefore a portion having a nanoindentation hardness that increases from the proximal end side toward the distal end side on the distal end portion of the reduced diameter portion exists).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Henderson in view of Satou and Purtzer, and further in view of Tadahiro (JP 2015024019 A, hereinafter Tadahiro; an attached machine translation was relied upon for this rejection).
Regarding Claim 22, modified Henderson discloses the guide wire according to claim 1. Modified Henderson discloses the claimed invention except for expressly disclosing the guide wire further comprising: a coil body that covers at least a distal end side of the first core shaft, and the second core shaft; and
a covering portion disposed inside the coil body and covering a joint part between the first core shaft and the second core shaft.
However, Tadahiro, which also discloses a guide wire (Abstract), teaches a coil body (Element 30, Fig. 11) that covers at least a distal end side of the first core shaft, and the second core shaft (See Fig. 11; “a first coil body 30 that is wound around a distal end of the core shaft 20…The core shaft 20 comprises a first shaft 21, and a second shaft 22 joined to a proximal end of the first shaft 21, and a connection part 24 of the first shaft 21 and the second shaft 22 is provided at the second fixing part 12”, Abstract); and
a covering portion (Element 32, Fig. 11) disposed inside the coil body (“The guide wire 40 according to the second embodiment includes a second coil body 32 that covers the core shaft 20 (first shaft 21) inside the first coil body 30”, page 4, paragraph 5) and covering a joint part (Element 24, Fig. 11) between the first core shaft and the second core shaft (“The proximal end portion of the second coil body 32 covers the joint portion 24 between the first shaft 21 and the second shaft 22”, page 4, paragraph 6). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify Henderson with, because the coil body, and the covering portion can function as a reinforcing member that reinforces the joint portion between the first core shaft and the second core shaft, as taught by Tadahiro (see page 4, paragraph 6).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Henderson in view of Satou, Purtzer and Tadahiro, and further in view of Naohiko (EP 2865406 A1, hereinafter Naohiko).
Regarding Claim 23, modified Henderson discloses the guide wire according to claim 17. Modified Henderson discloses the claimed invention except for expressly disclosing the guide wire further comprising:
a coil body that covers at least a distal end side of the first core shaft, and the second core shaft; and
a covering portion disposed inside the coil body and covering a joint part between the first core shaft and the second core shaft, wherein the covering portion covers, in addition to the joint part, a distal end side of the reduced diameter portion of the first core shaft.
However, Tadahiro, which also discloses a guide wire (Abstract), teaches the guide wire further comprising:
a coil body (Element 30, Fig. 11) that covers at least a distal end side of the first core shaft , and the second core shaft (See Fig. 11; “a first coil body 30 that is wound around a distal end of the core shaft 20…The core shaft 20 comprises a first shaft 21, and a second shaft 22 joined to a proximal end of the first shaft 21, and a connection part 24 of the first shaft 21 and the second shaft 22 is provided at the second fixing part 12”, Abstract); and
a covering portion (Element 32, Fig. 11) disposed inside the coil body (“The guide wire 40 according to the second embodiment includes a second coil body 32 that covers the core shaft 20 (first shaft 21) inside the first coil body 30”, page 4, paragraph 5) and covering a joint part (Element 24, Fig. 11) between the first core shaft and the second core shaft (“The proximal end portion of the second coil body 32 covers the joint portion 24 between the first shaft 21 and the second shaft 22”, page 4, paragraph 6). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify Henderson with, because the coil body, and the covering portion can function as a reinforcing member that reinforces the joint portion between the first core shaft and the second core shaft, as taught by Tadahiro (see page 4, paragraph 6).
Naohiko teaches wherein the covering portion covers, in addition to the joint part, a distal end side of the reduced diameter portion of the first core shaft (See Fig. 11; a coil body 93 covers the reduced diameter portion of the core shaft). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Henderson in view of Naohiko, because all of the claimed elements were known in the prior art before the effective filing date of the claimed invention, and one with ordinary skill in the art could have combined all the claimed elements by known methods, and the result would have been obvious to one of ordinary skill in the art (See [0063] of Naohiko).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
See Eskuri (US 20130226033 A1).
See Nowak, Jr. (US 20100292613 A1).
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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/JONATHAN E. COOPER/Examiner, Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791