DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-5 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites a resilience rate of a wire measured by a bending test. The bending test for measuring a resilience rate of a wire is not a standardized testing method. The resilience rate of a wire depends on the length and the diameter of a wire and holding time during the bending test. Without reciting these parameters, the recited resilience rate is indefinite. Appropriate correction is required.
Claim 1 recites “where θ is an angle of intersection between two tangent lines extending from the ends of the wire material after bending” in line 8-9. Two tangent lines extending from the ends of the wire material after bending form two angles that are supplementary to each other. As shown in Fig. 4 in instant Specification, the two tangent lines form two angles: an acute angle and an obtuse angle. Without defining which angle is ø, the recited resilience rate is indefinite. Appropriate correction is required.
Claim 3 recites a steel composition conforming to ASTM F2581. The applicants are suggested to recite the steel composition defined by ASTM F2581 to improve claim clarity. Appropriate correction is required.
Claim 4 recites no breakage occurs at a bent portion when the wire material is bent 180°. According to claim 1, the whole wire is subjected to bending. It’s unclear which portion is defined as bent portion. Further, after bending, the wire is not straight and one of ordinary skill in the art would not understand how the recited 180º is measured between two curved lines. Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2 and 4-5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by JP’532 (JP 2012-075532).
Regarding claims 1-2 and 4, JP’532 teaches a guide wire made of stainless steel SUS316 and having a tensile strength of 321 kgf/mm2 (i.e. 3145.8 N/mm2 after unit conversion) (Abstract; Page 4; Table 2, Wire 1f), which meet the stainless steel limitation recited in claim 1 and the tensile strength limitation recited in claim 2.
JP’532 does not explicitly disclose the resilience rate as recited in claim 1 and the property limitation as recited in claim 4. However, these property limitations depend on the steel composition and a method of making the wire. JP’532 discloses that the wire is made of stainless steel (Abstract; Page 4), the same type of steel as recited in claim 1. JP’532 discloses that the process of making the wire comprises cold drawing a wire rod at an area reduction rate of 97% followed by heat treatment at 420 ºC for 75 minutes (Abstract; Page 4; Table 2, Wire 1f), which meets the wire-making processing conditions disclosed in Paragraphs [0029] to [0031] of instant Specification.
In view of the fact that JP’532 teaches a wire made of stainless steel that is the same type of steel as recited in claim 1 and the wire is made under processing conditions 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 to meet the property limitations recited in claims 1 and 4. “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 claim 5, 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 claim 5.
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 1-5 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 1-4, JP’532 teaches a medical guide wire made of stainless steel SUS316 and having a tensile strength of 321 kgf/mm2 (i.e. 3145.8 N/mm2 after unit conversion) (Abstract; Page 4, Table 2, Wire f), which meet the stainless steel limitation recited in claim 1 and the tensile strength limitation recited in claim 2.
JP’532 does not explicitly disclose the resilience rate as recited in claim 1, the steel composition conforming to ASTM F2581 as recited in claim 3, and the property limitation as recited in claim 4. However, the property limitations recited in claims 1 and 4 depend on the steel composition and a method of making the wire.
JP’532 discloses that the wire is made of SUS316 stainless steel (Page 4), not ASTM F2581 steel as recited in claim 3. 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 3.
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 300-495 ºC for 30 seconds to 180 minutes, 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 3 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 4. “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 claim 5, 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 claim 5.
Conclusion
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith Hendricks can be reached at 5712721401. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/XIAOWEI SU/Primary Examiner, Art Unit 1733