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
Claims 2 and 11-25 have been cancelled, claim 1 has been amended; claim 26-27 are added as a new claim; claims 4-10 have been withdrawn as non-elected claims; Claims 1, 3, and 26-27 remain for examination, wherein claim 1 is an independent claim.
Previous Rejections/Objections
Previous rejection of Claim 2 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn since claim 2 has been cancelled in view of the Applicant’s “Arguments/Remarks with amendment” filed on 05/14/2026.
Previous rejection of Claim 2 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JP’303) in view of Taguchi et al (US-PG-pub 2015/0013820 A1, listed in IDS filed on 02/19/2025, thereafter PG’820) is withdrawn since claim 2 has been cancelled in view of the Applicant’s “Arguments/Remarks with amendment” filed on 05/14/2026.
However, In view of the Applicant’s “Arguments/Remarks with amendment” filed on 05/14/2026, newly recorded reference(s), and reconsideration, a new rejection has been listed in the following:
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, 3, and 26-27 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. 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 1 recites the broad recitation “Ni: ≤ 0.05 wt%” on line 9, and the claim also recites “nickel-free austenitic stainless steel” on line 1, 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. Claims 2 and 26-27 depend on claim 1, they are also rejected.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 26-27 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 26-27 depend on claim 1, while claim 1 indicates “a nickel-free” stainless steel, while claim 26 specify intended adding 0.02-0.05 wt% Ni and claim 27 specify including Ni, which contrary to the “a nickel-free” as claimed in the instant claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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, and 26-27 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 and 26-27, 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, S, 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 Claim 1, 26-27 (wt%)
From JP’303 (wt %)
Overlapping range
(wt %)
Cr
17-20 (cl.1, 26)
11-24
17-20
Mn
14-18 (cl.1, 26)
2-26
14-18
Mo
1-4 (cl.1, 26)
2.5-10
2.5-4
N
0.7-1.3 (cl.1, 26)
0.55-1.2
0.7-1.2
Si
≤ 0.75 (cl.1)
0.28-0.75 (cl.26)
Present (cl.27)
2 or less
≤ 0.75 (cl.1)
0.28-0.75 (cl.26)
Reads on (cl.27)
Cu
≤ 0.25 (cl.1, 26)
Present (cl.27)
5 or less
≤ 0.25
Reads on (cl.27)
C
≤ 0.03 (cl.1)
0.028-0.03 (cl.26)
Present (cl.27)
< 0.3
≤ 0.03 (cl.1)
0.028-0.03 (cl.26)
Reads on (cl.27)
S
≤ 0.01 (cl.1)
0.004-0.01 (cl.26)
Present (cl.27)
0.2 or less (cl.3 of JP’303)
≤ 0.01 (cl.1)
0.004-0.01 (cl.26)
Present (cl.27)
P
≤ 0.025 (cl.1)
0.005-0.025 (cl.26)
Present (cl.27)
Not intended added
0-impurity level (cl.1)
0.005-0.025 is within the impurity level (cl.26)
Reads on (cl.27)
Ni
≤ 0.05 (cl.1)
0.02-0.05 (cl.25)
Present (cl.27)
0.5 or less
≤ 0.05 (cl.1)
0.02-0.05 (cl.25)
Reads on (cl.27)
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).
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over JP’303 in view of PG’820, and further evidenced by Wang et al (CN 105002431 A. with on-line translation, thereafter CN’431).
Regarding the 0.005-0.025wt% P in the instant claim 26, P is considered as an inevitable impurity in an Ni-free austenitic stainless steel as evidenced by CN’431. CN’431 teaches Ni-free Cr-Mn-N austenitic stainless steel (Title, par.[0027], and abstract of CN’431). CN’431 specify that the inevitable impurity comprises phosphorus (P) and sulfur (S), according to the total mass of the stainless steel, wherein P is less than or equal to 0.035%, S is less than or equal to 0.030% (par.[0010] of CN’431), which overlap the claimed P range. MPEP 2144 05 I. Therefore, the inevitable impurities in the JP’303 in view of PG’820 may including less than or equal to 0.035 wt% P as inevitable impurity evidenced by CN’431 since JP’303 also include inevitable impurities in the alloy (claims of JP’303).
Response to Arguments
Applicant’s arguments to the art rejection to Claim(s) 1, 3, and 26-27 have been considered but they are not persuasive in view of the new ground rejection as stated above. Regarding the arguments related to the amendments in the instant claims, the Examiner’s position has been stated as following.
The Applicant’s arguments have been summarized as following:
1, Even assuming some compositional overlap , that does not establish obviousness of the present claimed tube because SPEIDEL MARKUS et al (JP’303) does not disclose nor teach the claimed combination of microstructure state, dimensional tolerances, strength, elongation, property thresholds, and pitting potential recited by claim 1.
2, SPEIDEL MARKUS et al (JP’303) provides only 15% elongation after 40% cold deformation, which far below the claimed axial elongation rate of 50% or more. And nor any evidence in Office Action to show SPEIDEL MARKUS et al (JP’303) necessarily or inherently posses the claimed pitting potential of 1000mV or more.
3, Taguchi et al (PG’820) merely states tube dimension, while the “uneven thickness” disclosed by Taguchi et al (PG’820) is not the same claimed feature as a wall thickness size deviation.
In response,
Regarding the argument 1, SPEIDEL MARKUS et al (JP’303) in view of Taguchi et al (PG’820) teaches an austenitic steel alloy with similar alloy composition, same austenitic structure, same grain size, similar properties for the same stainless thin tube application in the same medical devices, instrument application as
Regarding the argument 2, SPEIDEL MARKUS et al (JP’303) clearly indicates the 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). JP’303 provides examples having value of TS, YS, and Elongation being within the claimed ranges and specify that the alloy has twice as good corrosion resistance: comparable to the corrosion resistance of “Super Austenite” (par.[0024] and [0028] of JP’303). The Applicant does not provide evidence to show the claimed alloy has unexpected properties due to the criticality of the claimed alloy composition ranges.
Regarding the argument 3, Taguchi et al (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 m, 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 m. (par.[0089] of PG’820). The outer diameter deviation and wall thickness size deviation depends on the surface roughness and uneven thickness of the tube. Therefore, the disclosure of Taguchi et al (PG’820) reads on the claimed tube dimensions as claimed in the instant claims.
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 extension fee 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 date of this final action.
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 on IFP.
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/JIE YANG/Primary Examiner, Art Unit 1734
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