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 & Status of Claims
Applicant's election with traverse of claims 1-11 in the reply filed on 03/03/2026 is acknowledged. The traversal is on the ground(s) that the prior art of record does not teach the amended claim and therefore all claims be examined. This is not found persuasive because although Applicant has amended claim 1 upon receipt of the restriction/election requirement dated 01/20/2026, the prior art of record still reads on the amended claim (please see below).
The requirement is still deemed proper and is therefore made FINAL.
Claims 12-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 03/03/2026.
Specification
The disclosure is objected to because of the following informalities:
Instant specification recites references to claims such as “according to claim 1”, “according to claim 12”, “according to claim 15”, “according to claim 16” rather than incorporating/reciting the elements/limitations in the specification. See pages 1, 6 of instant specification.
The term “Tab.” should be replaced with “Table” for all tables in the specification.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
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 1-11 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for an extruded Mg based alloy with between 0.15 and 1.0 wt% of calcium, does not reasonably provide enablement for any alloy having any amounts of Mg and Ca as recited in the instant claims. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
MPEP § 2164.01(a) indicates that there are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is "undue." These factors include, but are not limited to:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
While the analysis and conclusion of a lack of enablement are based on the factors discussed in MPEP § 2164.01(a) and the evidence as a whole, it is not necessary to discuss each factor in the enablement rejection. Instead, the explanation of the rejection should focus on those factors, reasons, and evidence that lead the examiner to conclude e.g., that the specification fails to teach how to make and use the claimed invention without undue experimentation, or that the scope of any enablement provided to one skilled in the art is not commensurate with the scope of protection sought by the claims. This can be done by making specific findings of fact, supported by the evidence, and then drawing conclusions based on these findings of fact. For example, doubt may arise about enablement because information is missing about one or more essential parts or relationships between parts which one skilled in the art could not develop without undue experimentation. In such a case, the examiner should specifically identify what information is missing and why one skilled in the art could not supply the information without undue experimentation. See MPEP § 2164.06(a). References should be supplied if possible to support a prima facie case of lack of enablement, but are not always required. In re Marzocchi, 439 F.2d 220, 224, 169 USPQ 367, 370 (CCPA 1971). However, specific technical reasons are always required. See also MPEP § 2164.04.
In the instant case, the instant specification sets forth as follows.
Prior Art
In the last years, a promising new class of biodegradable implant materials—magnesium and its alloys—emerged and has attracted considerable attention.
Extruded Mg—Ca alloys with a Ca content of 0.8 wt % as base material for biodegradable implants were described in (Krause et al., 2010).
WO 2014/001321 A1 describes a magnesium alloy consisting of magnesium and calcium. The material is subjected to multiple processing steps such as multiple extrusions and multiple heat treatments before and after extrusions.
CN101015711B describes binary Mg—Ca alloys with examples provided for different compositions.
Summary of the invention
Here, the billet comprising magnesium and calcium means that material comprising magnesium and calcium is extruded in an extrusion equipment. Said billet comprising magnesium and calcium preferably corresponds to a magnesium-calcium alloy, also referred to as a Mg—Ca-alloy.
The billet being extruded at an extrusion temperature in the range of 250° C. to 450° C. means that the billet or Mg—Ca-alloy, i.e. the intermediate alloy, is held at a temperature in said range while it is extruded, for example being pushed through the die of an extrusion equipment.
The billet can furthermore comprise zirconium and/or hafnium. In other words, the method can comprise the step of generating a billet comprising magnesium, calcium and zirconium and/or hafnium, i.e. a Mg—Ca—Zr intermediate alloy, a Mg—Ca—Hf intermediate alloy or a Mg—Ca—Zr—Hf intermediate alloy can be produced. Consequently, the alloy produced in the method, i.e. the final alloy or target alloy, can comprise magnesium, calcium and additionally also zirconium and/or hafnium. Again, in other words, an alloy comprising or consisting of magnesium and calcium, i.e. a Mg—Ca alloy, can be produced. However, it is likewise conceivable that an alloy comprising or consisting of magnesium and calcium and zirconium, i.e. a Mg—Ca—Zr alloy, is produced. Likewise, it is conceivable that an alloy comprising or consisting of magnesium and calcium and hafnium, i.e. a Mg—Ca—Hf alloy, is produced. It is furthermore conceivable that an alloy comprising or consisting of magnesium and calcium and zirconium and hafnium, i.e. a Mg—Ca—Zr—Hf alloy, is produced.
The alloy preferably comprises between 0.15% by weight and 1.0% by weight of calcium based on the total weight of the alloy. More preferably, the alloy comprises between 0.25% by weight and 0.7% by weight of calcium based on the total weight of the alloy. For instance, the alloy can comprise between 0.3% by weight and 0.65% by weight of calcium based on the total weight of the alloy. Or, the alloy can comprise between 0.4% by weight and 0.65% by weight of calcium based on the total weight of the alloy. Or, the alloy can comprise between 0.25% by weight and 0.4% by weight of calcium based on the total weight of the alloy. Or, the alloy can comprise between 0.6% by weight and 1.0% by weight of calcium based on the total weight of the alloy.
A more preferred Mg—Ca alloy comprises between 99.35% by weight to 99.75% by weight of Mg and between 0.25% by weight to 0.65% by weight of Ca. In other words, a more preferred Mg—Ca alloy comprises at least 99.35% by weight of Mg and at least 0.25% by weight of Ca.
A preferred Mg—Ca—Zr alloy comprises between 98.5% by weight to 99.845% by weight of Mg, between 0.15% by weight to 1% by weight of Ca, and between 0.005% by weight to 0.5% by weight of Zr. In other words, a preferred Mg—Ca—Zr alloy comprises at least 98.5% by weight of Mg, at least 0.15% by weight of Ca, and at least 0.005% by weight of Zr.
A more preferred Mg—Ca—Zr alloy comprises between 99.25% by weight to 99.745% by weight of Mg, between 0.25% by weight to 0.65% by weight of Ca, and between 0.005% by weight to 0.1% by weight of Zr. In other words, a more preferred Mg—Ca—Zr alloy comprises at least 99.25% by weight of Mg, at least 0.25% by weight of Ca, and at least 0.005% by weight of Zr.
A particularly preferred Mg—Ca—Zr alloy consists of 99.48% by weight of Mg, 0.45% by weight of Ca, and 0.07% by weight of Zr.
A preferred Mg—Ca—Hf alloy comprises between 98.5% by weight to 99.845% by weight of Mg, between 0.15% by weight to 1% by weight of Ca, and between 0.005% by weight to 0.5% by weight of Hf. In other words, a preferred Mg—Ca—Hf alloy comprises at least 98.5% by weight of Mg, at least 0.15% by weight of Ca, and at least 0.005% by weight of Hf.
A more preferred Mg—Ca—Hf alloy comprises between 99.25% by weight to 99.745% by weight of Mg, between 0.25% by weight to 0.65% by weight of Ca, and between 0.005% by weight to 0.1% by weight of Hf. In other words, a more preferred Mg—Ca—Hf alloy comprises at least 99.25% by weight of Mg, at least 0.25% by weight of Ca, and at least 0.005% by weight of Hf.
A particularly preferred Mg—Ca—Hf alloy consists of 99.48% by weight of Mg, 0.45% by weight of Ca, and 0.07% by weight of Hf.
A preferred Mg—Ca—Zr—Hf alloy comprises between 98.5% by weight to 99.845% by weight of Mg, between 0.15% by weight to 1% by weight of Ca, and in total between 0.005% by weight to 0.5% by weight of Zr and Hf. In other words, a preferred Mg—Ca—Zr—Hf alloy comprises at least 98.5% by weight of Mg, at least 0.15% by weight of Ca, and in total at least 0.005% by weight of Zr and Hf.
A more preferred Mg—Ca—Zr—Hf alloy comprises between 99.25% by weight to 99.74% by weight of Mg, between 0.25% by weight to 0.65% by weight of Ca, and in total between 0.01% by weight to 0.1% by weight of Zr and Hf. In other words, a more preferred Mg—Ca—Zr—Hf alloy comprises at least 99.25% by weight of Mg, at least 0.25% by weight of Ca, at least 0.005% by weight of Zr, and at least 0.005% by weight of Hf.
A particularly preferred Mg—Ca—Zr—Hf alloy consists of 99.48% by weight of Mg, 0.45% by weight of Ca, and in total 0.07% by weight of Zr and Hf.
See also Tables 1 and 2 which show all of the examples are MgCa alloys
See Tables 4, 5 and 6 that show only Mg and Mg based alloys
Therefore, the instant disclosure provides an extruded Mg based alloy with between 0.15 and 1.0 wt% of calcium and does not provide any guidance for an alloy that does not have this microstructure limitation, for example a steel, an aluminum alloy as is allowed/claimed by the instant claims.
Claims 5-11 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.
Regarding claims 4-11, claims 4-11 recite “and/or” preceding limitations. It is unclear to determine all of the combinations required by the “and/or” and therefore to determine the scope of the claims. Furthermore, it is unclear whether all of the limitations can coexist: for example, part of claim 1 recites “further comprising the step of coating at least part of the alloy, the coating being a plasma electrolytic anodization coating and/or an amorphous metallic coating and/or a fluoric conversion coating and/or a Mg(OH)2 coating and/or a calcium phosphate conversion coating and/or a hydroxy-apatite coating and/or an organic coating and/or a biodegradable polymer coating and/or a sol-gel coating.” Specifically, one of the combinations would be “the coating being a plasma electrolytic anodization coating AND an amorphous metallic coating AND a fluoric conversion coating AND a Mg(OH)2 coating AND a calcium phosphate conversion coating AND a hydroxy-apatite coating AND an organic coating AND a biodegradable polymer coating AND a sol-gel coating”. It is unclear how such a coating can exist or be made.
Regarding claim 4, 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 4 recites the broad recitation 0.5% by weight or less of zirconium, and the claim also recites between 0.005% zirconium by weight and 0.5% zirconium by weight which is the narrower statement of the range/limitation.
In the present instance, claim 4 recites the broad recitation 0.5% by weight or less of hafnium, and the claim also recites between 0.005% hafnium by weight and 0.5% hafnium by weight 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.
Additionally, first part of the above limitations recite “based on the total weight of the alloy” while the second part of the limitations do not recite it. For example, claim 4 recites “wherein the alloy comprises 0.5% by weight or less of zirconium based on the total weight of the alloy and/or wherein the alloy comprises between 0.005% zirconium by weight and 0.5% zirconium by weight”. It is unclear whether the weight% of second part is based on something other than the total weight of the alloy.
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 and 4-11 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2014/159328 A1 of Imwinkelried (WO’328).
Regarding claims 1-2 and 4-11, WO 2014/159328 A1 of Imwinkelried (WO’328) teaches {abstract, [0001]-[0014]} “an MgZnCa alloy composition and an implant having a three-dimensional structure based on such alloy composition” and a method of making it wherein the method comprises [0013] “(a) casting an alloy containing (i) commercially pure magnesium having a purity of at least 99,96 wt.%; and (ii) from 0.1 to 2.0 wt.% zinc having a purity of at least 99.9 wt.% and (iii) from 0.2 to 0.5 wt% calcium having a purity of a least 99.9 wt%, said casting preferably being performed in an inert atmosphere and an inert reaction vessel; (b) solution heat treating the cast alloy at two different temperatures wherein a first temperature is below an eutectic temperature of Mg-Zn and a second temperature is above the eutectic temperature of the ternary Mg-Zn-Ca system to thereby form a MgZnCa alloy containing from 0.1 wt. % Zn to 2 wt.% Zn and 0.2 wt% Ca to 0.5 wt% Ca (c) aging heat treatment between 100° C and 300° C; and (d) extruding the alloy into a desired shape.” [0033] “In still yet another embodiment, the MgZnCa alloy, having a plurality of nanosized precipitates being less noble than the Mg matrix, contains less than 50 ppm of total other elements.” [0034] “In such embodiments, the other elements can include one or more of Fe, Cu, Ni, Co, Si, Mn, Al, Zr and P.” [0050] “Preheating for extrusion is typically carried out at the extrusion temperature in a separate oven until the billet has reached a uniform temperature. The preheated billet is then transferred to the preheated extrusion chamber and extrusion is carried out.” [0050] “In an alternative embodiment, the aging heat treatment step may be replaced with a heat treatment performed during the extrusion step, e.g. , during preheating and extrusion. Preheating for extrusion is typically carried out at the extrusion temperature in a separate oven until the billet has reached a uniform temperature. The preheated billet is then transferred to the preheated extrusion chamber and extrusion is carried out. If precipitates form during this preheating step, it would be considered an aging treatment.” [0056] “Afterwards the billets were homogenized, i.e., solution treated (ZX50 alloys: 350°C/12h; ZX10 alloy: 350°C/12h plus 450°C/ 8h) followed by cooling with pressurized air.” [0057| “The homogenized alloys were machined to billets with 50 mm in diameter and 120 mm in length. For XHP ZX10, the billet was aged at 250°C for 30 min in order to create fine and homogeneously distributed intermetallic particles (precipitates) prior to the extrusion process. Afterwards the billet was heated to 300°C and indirect extrusion was performed at a ram speed of 0.15 mm/s to a rod profile with a diameter of 10 mm, corresponding to an extrusion ratio of 25: 1. Cooling with pressurized air was applied at the exit side of the extrusion press. For the ZX50 alloys the extrusion to 10 mm diameter was performed by direct extrusion at 325°C. It has been found that indirect extrusion leads to higher rates of dynamic recrystallization.” [0055] “For purposes of further disclosure, certain high Zn-containing alloys (MgZn5Ca0.25), referred to as ZX50, were prepared along with lower Zn alloys as disclosed herein, such as MgZnlCaO.3, referred to as ZX10. The alloys were also prepared with varying degrees of purity; "Conventional purity" (CP), "high purity" (IIP), and "vacuum-distilled ultra-high purity" (XHP).” [0058] “In order to check the influence of trace elements on degradation performance, ZX50 alloys were prepared using high-purity (HP) Mg and vacuum-distilled ultra-high purity (XHP) Mg (see WO2013/ 107644 regarding vacuum distillation of high purity Mg, incorporated herein by reference).” [0056] “For the XHP alloys ZX50 and ZX10, distilled ultra-pure Mg (99.999%), Ca (99.99%), and Zn (99.999%) were synthesized in a graphite crucible under a protective gas mixture at 750°C.” [0063] “In order to avoid formation of the ternary MgeZn3Ca2 phase, it is seen that the Zn content should be below ~ 1.0 wt%, but in order to also benefit from some solid solution hardening, 1 wt% was chosen for the ZX10 alloy, and the content of Ca was evaluated along with the grain-refining effect of Mg2Ca particles. To create a very fine particle size, a solution treatment followed by an ageing procedure below or at the hot forming temperature was performed (see extrusion method above), FIG. 4B shows (a) the width of the solution treatment window Δ'1' ST (Zn and Ca are completely dissolved in Mg and the solidus temperature is still not reached) at a Zn content of 1 wt% and (b) the influence of the Ca. content on the width of the solution treatment window. In this case, 0.3wt% Ca was chosen. The constitution of the Zn-lean alloy MgZnlCaO.3 (ZX10) is shown in FIG. 4A. At 300°C only the Mg2Ca phase is present, Mg2Ca and (Mg,Zn)2Ca are equivalent; Mg2Ca can contain some Zn without changing its nature.”
The teachings of the prior art therefore reads on “A method of producing an alloy comprising magnesium and calcium, the method comprising the steps of: generating a billet comprising magnesium and calcium; and extruding the billet, wherein the billet is extruded at least once at an extrusion temperature in the range of 250° C to 450° C and at a ram speed in the range of 0.01 mm/s to 1 mm/s” of instant claim 1, the compositional requirements of instant claim 2 and 4, the vacuum distillation of instant claim 5 as well as recited limitations of instant claims 6-11.
Regarding the recited amended limitation of “an extrusion ratio in the range of 20 to 150”, it is noted that the amended range is a retreated range from the originally disclosed range of “20 to 150”. The prior art teaches “[0057| The homogenized alloys were machined to billets with 50 mm in diameter and 120 mm in length. For XHP ZX10, the billet was aged at 250°C for 30 min in order to create fine and homogeneously distributed intermetallic particles (precipitates) prior to the extrusion process. Afterwards the billet was heated to 300°C and indirect extrusion was performed at a ram speed of 0.15 mm/s to a rod profile with a diameter of 10 mm, corresponding to an extrusion ratio of 25: 1.” MPEP § 2144.05 I provides the guidance that Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner,778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of "having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium" as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium. "The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties."). It is also noted that the instant specification provides no distinguishable properties between 25 and 35 extrusion ratio and therefore does not provide any criticality of the claimed narrow range. Therefore, the claimed range of the instant claim is obvious over that of the prior art since the claimed value is close to the value provided by the prior art and there is no evidence on the record that the difference of 25 vs 35 for the extrusion ratio would provide different distinguishable properties as the instant specification discloses a range of 20 to 150 for extrusion ratio. In addition, MPEP provides that with regard to the shape/size/proportion, merely changing the shape/size/proportion of a prior art product would not be sufficient to distinguish from that prior art product as it has been held that changing the shape/size/proportion would require only ordinary skill in the art and hence are considered routine expedients. See MPEP § 2144.04 (IV). Therefore, making the specific ratios as claimed in the instant claims would require only ordinary skill in the art since thickness modification using extrusion is well known in the art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOPHY S. KOSHY whose telephone number is (571)272-0030. The examiner can normally be reached M-F 8:30 AM- 5:00 PM.
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/JOPHY S. KOSHY/Primary Examiner, Art Unit 1733
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