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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-9 in the reply filed on October 10,2025 is acknowledged. Claims 10-20 are withdrawn from consideration.
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 4 and 8 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 4 requires that the implant magnesium alloy comprises a plurality of a-Mg grains; and the plurality of a-Mg grains have an average grain diameter of 0.8 m or more and 2.5 m or less. It is not clear if the average grain diameter is taken from all of the a-Mg grains in the sample or just a plurality of a-Mg grains. If the average grain diameter is taken from all the a-Mg grains, then other grains (not a-Mg grains) would not be included in the average. If the average grain diameter is taken from just a plurality of a-Mg grains, then other grains (not a-Mg grains) could be included in the average. The specification does not provide clarity and one of ordinary skill in the art would not be apprised of the scope of the claim.
Claim 8 requires that the magnesium alloy “does not contain an unavoidable amount or more of Al”. As written, it is unclear what is intended by the phrase “does not contain an unavoidable amount” of a certain component, as any unavoidable amount would appear impossible to exclude, and thus would necessarily be present.
Further, it is unclear whether the claimed invention can or cannot contain an unavoidable amount of Al. This is, in part, due to the phrase “unavoidable amount or more”. Applicant could re-phrase the claim to “does not contain more than an unavoidable amount of Al” to provide clarity, if this accurately addresses applicant’s intended meaning. In response, Applicant is encouraged to demonstrate support in the specification for any amendments.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2, 5,7-9 are rejected under 35 U.S.C. 103 as being unpatentable over US20120269673 of Koo.
Claim 1 requires 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 x and y satisfy 0.15 ≤ x ≤ 1.5 and 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. Therefore, Koo teaches 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 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 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 teaches all limitation of claim 7.
Claim 8 further limits claim 1 by requiring that the magnesium alloy does not contain an unavoidable amount or more of Al. It is unclear whether an unavoidable amount of Al can be included, see 112(b) above. For the purposes of prior art this will be interpreted as encompassing an unavoidable amount of Al.
Koo discloses examples of the alloying element that may be included in the magnesium alloy, Para[0022], and Al is not included. Koo teaches that the alloy comprises greater than 0 wt% but not greater than 23 wt% of calcium (Ca), greater than 0 wt% but not greater than 10 wt % of the alloying element, and the balance of magnesium (Mg), Para[0027]. Aluminum is not included in this composition. Therefore, Koo teaches all limitations of claim 8.
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 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 WO2018083998 of Kawamura.
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 Kawamura covers all limitations of claim 3.
Claim 4 states that the magnesium alloy comprises a plurality of α-Mg grains; and the plurality of α-Mg grains have an average grain diameter of 0.8 µm or more and 2.5 µm or less.
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 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 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 Imwinkelreid covers all limitations of claim 6.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACOB BENJAMIN STILES whose telephone number is (571)272-0598. The examiner can normally be reached Monday-Friday 7:30am - 5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith Hendricks can be reached at (571) 272-1401. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Keith D. Hendricks/Supervisory Patent Examiner, Art Unit 1733
/JACOB BENJAMIN STILES/Examiner, Art Unit 1733