DETAILED ACTION
Response to Amendment
The Amendment filed 15 May 2026 has been entered. Claims 1-7 and 9 remain pending in the application. Claims 10-20 have been withdrawn. Claim 8 has been canceled. No new claims have been added. Applicant's amendments to the claims have overcome the 112(b) rejections previously set forth in the Non-Final Rejection mailed 22 January 2026.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 19 September 2022 was considered by the examiner. The submission is in compliance with the provisions of 37 CFR 1.97.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-2, 5, 7, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over US20120269673 of Koo in view of KR20150050586 (machine translation) of Beck.
Claim 1 claims an implant magnesium alloy, comprising: x at% of Zn; a total of y at% of at least one element of Ca and Sr; and the balance of Mg and inevitable impurities, wherein the magnesium alloy has tensile yield strength of 260 MPa or more, and x and y satisfy formulae 1 and 2 below, (Formula 1) 0.15<x<1.5 (Formula 2) 0.5<y<1.5.
Koo discloses a magnesium alloy in the same field of endeavor as the claimed invention, which comprises magnesium (Mg) and an alloying element and includes a magnesium phase and a phase composed of magnesium and the alloying element, Para[0020]. Examples of the alloying element include calcium (Ca), strontium (Sr), and zinc (Zn), Para[0023]. Koo teaches a range for Co of 0-23 wt%, and a range for zinc of 0.1-5 wt%, and the balance Mg, Para[0029]. This corresponds to 0-15.9 at% Co, and less than 0 to 2.10 at% Zn. These ranges both overlap with the claimed ranges. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists, see MPEP 2144.05. While Koo does not disclose the numerical limitation related to tensile yield strength of claim 1, Koo teaches an alloy with a composition that meets the compositional limitations of claim 1. Products of identical chemical composition cannot have mutually exclusive properties, see MPEP 2112.01. Therefore, the alloy disclosed in Koo would necessarily exhibit the properties of the claimed invention, including tensile yield strength. Therefore, Koo teaches all limitations of claim 1.
Additionally, Beck teaches ultrapure magnesium alloy with adjustable degradation rate in the same field of endeavor as the claimed invention. Beck discloses that the present invention relates to a magnesium alloy with improved decomposition properties, Para[0002]. Beck teaches overlapping ranges for Zn and Ca, Para[0010], and overlapping ranges for tensile yield strength, at least 380 MPa, Para[0047]. Therefore, it would be obvious to one of ordinary skill in the art to produce the alloy disclosed by Koo achieving a yield strength taught by Beck in order to achieve improved decomposition properties. Thus, Koo in view of Beck covers all limitations of claim 1.
Claim 2 further limits claim 1 by requiring the magnesium alloy to comprise a at% of Mn, where a satisfies 0.01 ≤ a ≤ 0.08.
Koo teaches a range for Mn of 0.1-5 wt%, Para[0029]. This corresponds to less than 0 to 2.50 at% Mn. This overlaps with the claimed range. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists, see MPEP 2144.05. Therefore, Koo in view of Beck teaches all limitations of claim 2.
Claim 5 further limits claim 1 by requiring the magnesium alloy to comprise at least one of compounds of Mg2Ca and Mg17Sr2.
Koo discloses the Mg2Ca compound, Table 4. Koo teaches two graphic diagrams involving the magnesium alloy containing Mg2Ca, Para[0065],[0067]. Thus, Koo in view of Beck teaches all limitations of claim 5.
Claim 7 further limits claim 1 by requiring that the magnesium alloy does not have a compound of Mg6Ca2Zn3 in a constituent phase determined by X-ray diffraction.
Koo teaches a magnesium alloy that satisfies Mga Cab Xc, where a, b, and c represent molar fraction of the respective components and a+b+c=1, 0.5≦a<1, 0≦b≦0.4, and 0≦c≦0.4, Para[0023]. Since a cannot be 6, the Mg6Ca2Zn3 compound cannot be included in the alloy. Therefore, Koo in view of Beck teaches all limitation of claim 7.
Claim 9 claims a bone fixture comprising the implant magnesium alloy from claim 1.
Koo teaches that the magnesium alloy will reflect less light in an operating room so as not to interfere with vision, and gives an elegant feel. In addition, when the surface of the magnesium becomes rough, the adhesion of bone to the surface can be improved, Para[0060]. Therefore, it would be obvious to one of ordinary skill in the art to use the magnesium alloy in a bone fixture. Thus, Koo in view of Beck teaches all limitations of claim 9.
Claims 3 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over US20120269673 of Koo in view of KR20150050586 (machine translation) of Beck, as cited above, further in view of WO2018083998 (machine translation) of Kawamura.
Claim 3 further limits claim 1 by claiming that the magnesium alloy contains z at% of RE (rare-earth element), wherein z satisfies formula 4 below,(Formula 4) 0<z<0.
Koo discloses a magnesium alloy in the same field of endeavor as the claimed invention, which comprises magnesium (Mg) and an alloying element and includes a magnesium phase and a phase composed of magnesium and the alloying element, Para[0020]. Koo does not disclose rare-earth elements in the alloy composition.
Kawamura discloses a bioabsorbable medical device and method for producing the same in the same field of endeavor as the claimed invention. Kawamura discloses rare earth elements in the range of 0.1-2.5 at%, Para[0006]. This overlaps with the claimed range. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists, see MPEP 2144.05. Kawamura teaches that precipitates such as compounds precipitated inside each of the plurality of α-Mg particles are precipitates of a compound of Mg and a rare earth element is good, Para[0006]. Kawamura also teaches that by applying one embodiment of the present invention, it is possible to provide a bioabsorbable medical device comprising a magnesium alloy having high strength and low bio absorption rate, or a method of manufacturing the same, Para [0004]. Therefore, it would be obvious to one of ordinary skill in the art to add rare earth elements in the amounts disclosed in Kawamura to the magnesium alloy disclosed in Koo to achieve an alloy with high strength and low bio absorption rate. Thus, Koo in view of Beck and Kawamura covers all limitations of claim 3.
Claim 4 states that the magnesium alloy comprises α-Mg grains; and the α-Mg grains have an average grain diameter of 0.8 µm or more and 2.5 µm or less, the average grain diameter is taken from all of the a-Mg grains of the magnesium alloy.
Koo discloses a magnesium alloy in the same field of endeavor as the claimed invention, which comprises magnesium (Mg) and an alloying element and includes a magnesium phase and a phase composed of magnesium and the alloying element, Para[0020]. Koo does not disclose a plurality of α-Mg grains or an average grain diameter.
Kawamura discloses a bioabsorbable medical device and method for producing the same in the same field of endeavor as the claimed invention. Kawamura teaches a plurality of α-Mg grains with average particle size of 2 µm or less, Para[0004]. This overlaps with the claimed range. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists, see MPEP 2144.05. Kawamura teaches that by reducing the average particle size to this range, the magnesium alloy has high strength and the bio absorption rate can be reduced, Para[0004]. Therefore, it would be obvious to one of ordinary skill in the art to reduce the average grain diameter of the α-Mg grains to the range disclosed in Kawamura while producing the alloy disclosed in Koo to produce an alloy with high strength and a lower bio absorption rate. Thus, Koo in view of Beck and Kawamura covers all limitations of claim 4.
Claims 6 is rejected under 35 U.S.C. 103 as being unpatentable over US20120269673 of Koo in view of KR20150050586 (machine translation) of Beck, as cited above, further in view of WO2014159328 of Imwinkelreid.
Claim 6 further limits claim 5 by requiring the at least one compound to have an average grain diameter of 0.07 µm to 0.29 µm.
Koo discloses a magnesium alloy in the same field of endeavor as the claimed invention, which comprises magnesium (Mg) and an alloying element and includes a magnesium phase and a phase composed of magnesium and the alloying element, Para[0020]. Koo does not disclose an average grain diameter for the at least one compound.
Imwinkelreid teaches a magnesium alloy with adjustable degradation rate in the same field of endeavor as the claimed invention. Imwinkelreid teaches a MgZnCa alloy system having the less noble fine precipitates, exhibits fine grain sizes less than 5 µm after extrusion of the casting billet, including less than 2 µm and less than 1 µm, Para[0048]. This overlaps with the claimed range. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists, see MPEP 2144.05. Imwinkelreid discloses that the fine-grained microstructure is not only necessary to achieve a better strength level but also needed to avoid mechanical anisotropy (strength difference between tension and compression), Para[0003]. Therefore, it would be obvious to one of ordinary skill in the art to refine the average grain diameter of the at least one compound disclosed in Koo to the range disclosed in imwinkelreid in order to achieve better strength and to avoid mechanical anisotropy. Thus, Koo in view of Beck and Imwinkelreid covers all limitations of claim 6.
Response to Arguments
Applicant's arguments filed 15 May 2026 have been fully considered but they are not persuasive. Applicant argues that (remarks, pages 8, 9 of 10) primary reference Koo does not teach or suggest “wherein the magnesium alloy has tensile yield strength of 260 MPa or more”. This is not found persuasive as Koo discloses an alloy with overlapping ranges for all the compositional limitations of claim 1, and products of identical chemical composition cannot have mutually exclusive properties, see MPEP 2112.01. Therefore, Koo inherently covers the yield strength of the instant invention.
Additionally, Beck also teaches an alloy with overlapping ranges for all compositional limitations of claim 1 and also discloses and overlapping range for yield strength, at least 380 MPa, Para[0047]. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists, see MPEP 2144.05. Therefore, Koo in view of Beck covers all limitations of claim 1.
Thus, the rejection is maintained.
Examiner’s Note
Examiner has attached a previously-cited foreign reference that was inadvertently omitted in the non-final action. Reference Included: WO2014159328
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.
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/Keith D. Hendricks/Supervisory Patent Examiner, Art Unit 1733
/JACOB BENJAMIN STILES/Examiner, Art Unit 1733
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