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 .
Status of Claims
Claims 1 and 5 are amended. Claims 3-4 are cancelled. Claim 6 is new. Claims 1-2 and 5-6 are pending.
Status of Previous Rejections
The rejections of claims 1-5 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, have been withdrawn in view of the amendment.
The rejection of claims 1-2 and 4-5 under 35 U.S.C. 102(a)(1) as being anticipated by JP’532 (JP 2012-075532) have been withdrawn in view of the amendment.
The rejections of claims 1-2 and 5 under 35 U.S.C. 103 as being unpatentable over JP’532 (JP 2012-075532), and further in view of Narayan (ASM Handbook, Vol 23, Materials for Medical Device, 2012) are maintained.
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.
Claims 1-2 and 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over JP’532 (JP 2012-075532), and further in view of Narayan (ASM Handbook, Vol 23, Materials for Medical Device, 2012).
Regarding claims 1-2, JP’532 teaches a medical guide wire made of austenite stainless steel SUS304 and SUS316 (Abstract; Page 4, Table 1, Wire 1b and 1d; Table 2, Wire f). JP’532 discloses that in order to make a medical guide wire having high tensile strength, the wire is made by wire drawing at a total area reduction ratio of 90 to 99.5% followed by a low temperature heat treatment at 180-525 ºC for 10 minutes to 180 minutes (Page 6-7). JP’532 discloses examples wherein the wire is made by two drawing with a heat treatment at 420 ºC for 75 minutes after the first drawing and the second drawing (See Table 1, Wire 1b and 1d; Table 2, Wire f).
JP’532 discloses that the wires are made of SUS304 and SUS316 stainless steel (Page 4), not ASTM F2581 steel as recited in claim 1. Narayan teaches stainless steels for making a medical guide wire (Page 207-208). Narayan discloses that nitrogen-strengthened stainless steels have been developed and standardized for making medical guide wires and nitrogen-strengthened stainless steels have increased corrosion resistance and improved mechanical properties when compared to SUS316 stainless steel (Page 207). Thus, it would be obvious to one of ordinary skill in the art to use nitrogen-strengthened stainless steels as taught by Narayan in the process of making a guide wire of JP’532 in order to make a medical guide wire having increased corrosion resistance and improved mechanical properties as disclosed by Narayan. Narayan discloses that examples of nitrogen-strengthened stainless steels include ASTM F2229 and ASTM F2581 (Page 207 to Page 208), which meets the steel composition recited in claim 1.
JP’532 in view of Narayan does not explicitly disclose the property limitations as recited in claims 1 and 2. However, the property limitations recited in claims 1 and 2 depend on the steel composition and a method of making the wire.
JP’532 further discloses that the process of making a wire comprises cold drawing a wire rod at an area reduction rate of 90-99% followed by a heat treatment at 180-525 ºC for 10 minutes to 180 minutes (Page 6-7), which meets the wire-making processing conditions disclosed in Paragraphs [0029] to [0031] of instant Specification.
In view of the fact that JP’532 in view of Narayan teaches a wire composition that meets the recited composition in claim 1 and a processing conditions of making the wire that meet the processing conditions disclosed in instant Specification, one of ordinary skill in the art would expect that the stainless steel wire disclosed by JP’532 in view of Narayan to meet the property limitations recited in claims 1 and 2. “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established.” In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). See MPEP 2112.01 I.
Regarding claims 5 and 6, JP’532 discloses a guided wire comprising the stainless-steel wire and a coil body provided around the stainless steel wire (Page 2, last 3 paragraphs), which meets the limitation recited in claims 5 and 6.
Response to Amendment
The Declaration under 37 CFR 1.132 filed 04/17/2026 is insufficient to overcome the rejection over JP’532 in view of Narayan as set forth in the last Office action because: JP’532 discloses examples wherein the heat treatment is performed at 420 ºC for 75 minutes after the first drawing and the second drawing (See Table 1, Wire 1b and 1d; Table 2, Wire f). The heat treatment temperature and time used in the Declaration is 520 ºC and 90 minutes, which are different from the heat treatment conditions used in the examples of JP’532. Therefore, the data presented by the applicants cannot be used as evidence to show that a wire made of ASTM F2581 steel under the processing condition of JP’532 would break during secondary drawing.
Response to Arguments
Applicant's arguments filed 04/17/2026 have been fully considered but they are not persuasive.
First, the applicants argued that Narayan (p. 207) lists nitrogen-strengthened stainless steels for guide wires as ASTM F1314, F1586, and F2229. ASTM F2581 is not listed. Therefore, even if JP532 were modified to adopt a nitrogen-strengthened stainless steel in view of Narayan, one of ASTM F1314, F1586, or F2229-not ASTM F2581-would have been selected. Accordingly, the austenitic stainless steel conforming to ASTM F2581, as recited by claim 1, would not have been obvious over JP532 in view of Narayan.
In response, Narayan discloses that F2229 is used for guide wire (Page 207, right column). Narayan further discloses that ASTM F2229 and ASTM F2581 are both nickel-free 200-series austenitic stainless steel (Page 208, left column, last paragraph; Page 208, right column, last paragraph). Since Narayan discloses that both ASTM F2229 and ASTM F2581 are nitrogen-strengthened nickel-free 200-series austenitic stainless steel and nitrogen-strengthened stainless steels have increased corrosion resistance and improved mechanical properties, one of ordinary skill in the art would be motivated to use ASTM F2581 in the process of JP’532 to make a guide wire having increased corrosion resistance and improved mechanical properties.
Second, the applicants argued that JP532 discloses subjecting SUS316 to primary wire drawing, primary low- temperature heat treatment, secondary wire drawing, and secondary low-temperature heat treatment. However, when the base wire material is changed, it is routine practice to modify the processing and heat-treatment conditions accordingly. Thus, even if JP532 was modified to use a wire material conforming to ASTM F2581, it cannot be assumed that the same processing conditions disclosed for SUS316 would be applied. Consequently, it cannot be concluded that the asserted combination of JP532 and Narayan would necessarily achieve the resilience rate or the absence of wire breakage, as recited in amended claim 1.
In response, since JP’532 discloses that the heat treatment conditions at 420 ºC for 75 minutes can be applied to both SUS 304 and SUS 316, one of ordinary skill in the art would be motivated to use the same heat treatment condition for making ASTM 2581 wire. JP’532 further discloses that the total area reduction ratio for wire drawing is 90% to 99.5%.
Third, the applicants argued that in a Rule 132 Declaration including experimental evidence in which a wire having the ASTM F2581 composition was processed in accordance with the teachings of JP532 (i.e., processing steps including primary wire drawing, primary heat treatment, secondary wire drawing, and secondary heat treatment). The results show that wire breakage occurred during the secondary wire drawing step. In addition, the broken wire fractured before reaching 180° when subjected to a bending test. In view of the results in the Declaration, even if JP532 is combined with Narayan, the claimed wire material would not be achieved, especially the absence of breakage at a bent portion of the wire material having maximum curvature when the wire material is bent back onto itself, as recited by claim 1. The Declaration precludes a finding that the recited absence of wire breakage is inherent to the applied references.
In response, JP’532 discloses examples wherein the heat treatment is performed at 420 ºC for 75 minutes after the first drawing and the second drawing (See Table 1, Wire 1b and 1d; Table 2, Wire f). The heat treatment temperature and time used in the Declaration is 520 ºC and 90 minutes, which are different from the heat treatment conditions used in the examples of JP’532. Therefore, the data presented by the applicants cannot be used as evidence to show that a wire made of ASTM F2581 steel under the processing condition of JP’532 would break during secondary drawing.
Fourth, the applicants argued that the claimed resilience rate of 96% or more and absence of wire breakage, which are shown in the Examples in the present application, would have been unexpected over the teachings of the JP532 and Narayan, which do not teach or suggest that a high resilience rate of 96% or more or the absence of wire breakage can be achieved. See, e.g., original application, " [0034]-[0062], including Tables 2, 4, and 5. Indeed, a person skilled in the art would not have reasonably expected that combining the teachings of JP532 and Narayan in the manner proposed by the Office Action would have increased the resilience rate to 96% or more, much less avoided wire breakage at a bent portion of the wire material having maximum curvature when the wire material is bent back onto itself.
In response, JP532 in view of Narayan discloses that the starting material is the same and the wire is produced under the same processing conditions as instant Specification, one of ordinary skill in the art would expect that the wire product disclosed by JP532 in view of Narayan to have the recited properties in claim 1.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Xiaowei Su whose telephone number is (571)272-3239. The examiner can normally be reached 8:00-5:00.
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/XIAOWEI SU/Primary Examiner, Art Unit 1733
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