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 .
DETAILED ACTION
Applicant elected Invention I and Species 1 (Claims 1-3), drawn to a product of a high-nitrogen nickel-free austenitic steel thin-wall tube, classified in class C22c38/001 without traverse. Regarding the Invention II (Claims 7-10), although these claim depend on claim 1 directly/indirectly, they are still recognized as process claims. Invention II and Inventions I are related as process of making and product made. The inventions are distinct if either or both of the following can be shown: (1) that the process as claimed can be used to make another materially different product or (2) that the product as claimed can be made by another materially different process (MPEP 806.05(f)). In the instant case, the product I (soluble Mg alloy) as claimed can be made by another materially different process, such as: powder metallurgical process. Therefore, the restriction is still proper. Therefore, Claims 4-25 are withdrawn from consideration as non-elected claims, Claims 1-3 remain for examination, wherein claim 1 is an independent claim.
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.
Claim 2 is 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. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 2 recites the broad recitation “Si: ≤ 0.75 wt%)” on line 3, and the claim also recites “Si: ≤ 0.01 wt%)” on line 4, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Proper amendment is necessary.
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.
Claim(s) 1-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over SPEIDEL MARKUS et al (JP H10183303 A, with on-line translation, thereafter JP’303) in view of Taguchi et al (US-PG-pub 2015/0013820 A1, listed in IDS filed on 02/19/2025, thereafter PG’820)
Regarding claims 1-2, JP’303 teaches an austenitic steel alloy having corrosion resistance, toughness and non-magnetism and being compatible to use for human skin and the interior of human body by limiting the composition of elements of steel alloy to a specified range with Ni not contained intentionally or limited to 0.5wt% at most (Abstract of JP’303), which reads on the Ni-free austenitic stainless steel as claimed in the instant claims. The comparison between the claimed alloy composition ranges and those disclosed by JP’303 (claims, par.[0005]-[0015] of JP’303) has been listed in following table. All of the alloy composition ranges disclosed by JP’303 overlaps the claimed alloy composition ranges, which creates a prima facie case of obviousness. MPEP 2144 05 I. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to optimize the alloy composition ranges including Cr, Mn, Mo, N, Si, Cu, C, P, Ni, and Fe from the disclosures of JP’303 as recited in the instant claims since JP’303 teaches the same Ni-free austenitic stainless steel as claimed throughout whole disclosing range. Regarding the claimed alloy properties TS, YS, Elongation and pitting potential, which are fully depended on the alloy composition and microstructures. JP’303 teaches the similar Ni-free austenitic stainless steel deformed by the same deformation to form austenitic stainless steel as disclosed in the instant invention for the same medical devices, instrument application (cl.10 and par.[0019] of JP’303), the claimed properties would be highly expected by the alloy of JP’303. MPERP 2112 01 and 2145 II. Actually the TS, YS, and elongation disclosed by JP’303 reads on the claimed properties. It is noted that JP’303 does not specify thin wall tube application and grain size as claimed in the instant claim 1. PG’820 teaches a nickel-free high-nitrogen stainless steel material made of a fine grain structure having a maximum crystal grain size of 30 mm or less for a thin wall-tube medical application (Abstract, example, and claims of PG’820). PG’820 provides example to have a thin seamless tube was intended to have an outer diameter of 1.4 mm, a wall thickness of 150 mm, and roundness of 0.01 mm to slip down an inclined plate having a straightness of 5o. In addition, it was intended to produce a thin seamless tube having an uneven thickness of ≤ 0.01 mm, a surface roughness Ra satisfying a relation of ≤ 0.5 mm. (par.[0089] of PG’820), which reads on the claimed wall thickness and deviation as claimed in the instant claim. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to manufacturing a thin-wall tube with Ni-free austenitic stainless steel with optimized grain size as demonstrated by PG’820 with the alloy of JP’303 since both of JP’303 and PG’820 teach the nickel-free high-nitrogen stainless steel material for medical device applications as claimed throughout whole disclosing range.
Element
From instant Claims 1-2 (wt%)
From JP’303 (wt %)
Overlapping range
(wt %)
Cr
17-20
11-24
17-20
Mn
14-18
2-26
14-18
Mo
1-4
2.5-10
2.5-4
N
0.7-1.3
0.55-1.2
0.7-1.2
Si
≤ 0.75
2 or less
≤ 0.75
Cu
≤ 0.75
5 or less
≤ 0.75
C
≤ 0.75
< 0.3
< 0.3
P
≤ 0.75
Not intended added
0-impurity level
Ni
≤ 0.75
0.5 or less
≤ 0.5
Fe
Balance + impurities
Balance + impurities
Balance + impurities
Properties
From claim 1
Par.[0024] of JP’303
Within range
YS (MPa)
600 or more
640
640
TS (MPa)
1000 or more
1080
1080
Elongation (%)
50 or more
63
63
Pitting potential (mV)
1000 or more
Twice as good corrosion resistance: comparable to the corrosion resistance of “Super Austenite”
MPEP 2112 01 and 2145 II.
Cold deformation(%)
66 or less
40 (cold forming)
40
Regarding claim 3, JP’303 teaches applying the Ni-free austenitic stainless steel for medical devices, instrument application (cl.10 and par.[0019] of JP’303).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JIE YANG whose telephone number is (571)270-1884. The examiner can normally be reached IFP.
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/JIE YANG/Primary Examiner, Art Unit 1734