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 .
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 4/25/23 has been considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of claims 1-20 in the reply filed on 12/3/25 is acknowledged.
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.
Claims 5-6 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 5 recites the limitation "cooling the fused metal granules ". Once the metal granules are fused, they are no longer granules, but a fused metal component. Accordingly, it is unclear if the granules are to be cooled prior to fusing, such as after thermal debinding, or if the fused metal component is to be cooled.
Claim 6 recites the limitation "the fused metal granules are cooled". Once the metal granules are fused, they are no longer granules, but a fused metal component. Accordingly, it is unclear if the granules are to be cooled prior to fusing, such as after thermal debinding, or if the fused metal component is to be cooled.
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 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.
Language from the reference(s) is shown in quotations. Limitations from the claims are shown in quotations within parentheses. Examiner explanations are shown in italics.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1-6, 8-14, 17, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Chreene et al. (US 20130226179 A1), in view of Niinomi et al., Advances in Metallic Biomaterials, chapter 2, Metal Injection Molding (MIM) Processing, DOI 10.1007/978-3-662-46842-5, 2015.
Regarding claim 1, Chreene teaches “an external fixation component includes a capture member defining opposing grooves on opposite lateral sides of the capture member for capture of an element, for example, a bar, rod, wire or pin, of an orthopedic fixation system by snapping onto the element from a direction generally perpendicular to a longitudinal axis of the element” (which reads upon “an orthopedic clamp component”, as recited in the instant claim; paragraph [0004]). Chreene teaches that “the head 32 is formed by, for example, a metal injection molded stainless steel frame” (which reads upon “a method of forming an orthopedic clamp component”, as recited in the instant claim; paragraph [0032]). Chreene teaches that “the recess 38 is defined between two opposing walls 54, and the recess 36 is defined between two opposing walls 68” (which reads upon “the mold having a plurality of void projections that are shaped to form a plurality of voids in a metal orthopedic clamp component, each void having one or more ribs around each void; and, the metal orthopedic clamp component having a first exterior surface having the plurality of voids corresponding to the plurality of void projections formed on the mold to define the plurality of ribs”, as recited in the instant claim; paragraph [0028] and FIG. 4). Chreene teaches that “the recess 38 may include an optional shelf 56” (paragraph [0028]; shelf 56 may be absent). Chreene teaches that “each head 32 has an aperture 46 and each base 30 has an aperture 44 for receiving the bolt 48 and the shaft 50” (which reads upon “at least one opening projection that forms an opening through the orthopedic clamp component”, as recited in the instant claim; paragraph [0024]). Chreene teaches that “each capture member 20 defines opposing grooves 22, 24 on opposite lateral sides 26, 28, respectively, of the capture member 20, and that the groove 24 is sized to capture a first element, for example, a bone pin 16, and the groove 22 is sized to capture a second element having a diameter greater than the diameter of the first element, for example, a rod 18, of the orthopedic fixation system” (which reads upon “a first periphery surface on the metal orthopedic clamp component having at least one pin groove”, as recited in the instant claim; paragraph [0020]). Chreene teaches that “the metal injection molded component provides strength and resistance to creep” (paragraph [0031]).
Chreene is silent regarding the specifics of metal injection molding. A patent need not teach, and preferably omits, what is well known in the art. See MPEP § 2164.01.
Niinomi is similarly concerned with metal injection molding of alloys suitable for biomedical applications (page 27). Niinomi teaches that “complex-shaped components can be obtained by net or near-net shaping through the powder metallurgy processing route such as metal injection molding (MIM) process” (page 27). Niinomi teaches that “the process has ability to produce the high degree of geometrical complexity of the component with high properties” (page 28). Niinomi teaches that “MIM uses the metal powder and binder plastics” (which reads upon “a metallic powder comprising metal granules”, as recited in the instant claim; page 27). Niinomi teaches that “powder and thermoplastic binder are mixed and kneaded in order to obtain the feedstock, and that this feedstock is heated and injected into a mold using a conventional injection molding machine” (which reads upon “comprising filling a mold with a metallic powder comprising metal granules”, as recited in the instant claim; page 28). Niinomi teaches that “after the injection process, the binder is removed by heating, chemical extraction, or catalytic reaction, and then this is followed by sintering process to produce the final parts” (which reads upon “fusing the metal granules in the mold to form the metal orthopedic clamp component”, as recited in the instant claim; page 28; sintering reads on fusing; Niinomi is silent regarding removing the part from mold prior to sintering; additionally or alternatively, selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results, MPEP § 2144.04 IV C).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to perform the method of Chreene to including filling a mold with a metallic powder comprising metal granules and fusing the metal granules in the mold to form the metal orthopedic clamp component, as taught by Niinomi because Niinomi teaches that these steps are part of the metal injection molding process.
Regarding claim 2, modified Chreene teaches the method of claim 1 as stated above. Niinomi teaches that “after the injection process, the binder is removed by heating, chemical extraction, or catalytic reaction, and then this is followed by sintering process to produce the final parts” (page 28). Niinomi teaches that “continuous sintering was performed in high vacuum (in the order of below 10 2Pa) at various temperatures” (page 33 and Table 2.2).
Regarding claim 3, modified Chreene teaches the method of claim 1 as stated above. Niinomi teaches that “MIM uses the metal powder and binder plastics” (page 27).
Regarding claim 4, modified Chreene teaches the method of claim 1 as stated above. Niinomi teaches that “after the injection process, the binder is removed by heating, chemical extraction, or catalytic reaction, and then this is followed by sintering process to produce the final parts” (page 28).
Regarding claims 5-6, modified Chreene teaches the method of claim 1 as stated above. Niinomi teaches that “thermal debinding was performed from room temperature to 703 K in reduced pressure with argon gas current, and continuous sintering was performed in vacuum (10 2 Pa order) at various temperatures for 14.4 ks, followed by furnace cooling” (page 40). Niinomi is silent regarding removing the part from mold prior to cooling; additionally or alternatively, selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results, MPEP § 2144.04 IV C.
Regarding claims 8 and 12-14, modified Chreene teaches the method of claim 1 as stated above. Chreene teaches that “the head 32 is formed by, for example, a metal injection molded stainless steel frame” (paragraph [0032]; steel reads on iron and nickel). Niinomi teaches that “MIM process is applicable for most of common engineering metals such as carbon steel, stainless steel, tungsten, nickel-based alloys, titanium alloys, etc.” (page 28). Niinomi teaches that “the properties of injection molded Ti-6Al-4V alloy compacts using alloy powders and various mixed powders were investigated comprehensively” (page 32). Niinomi teaches fine Al-40V powder with an average particle diameter of 6.4 μm (page 33).
Regarding claim 9, modified Chreene teaches the method of claim 1 as stated above. Niinomi teaches fine Al-40V powder with an average particle diameter of 6.4 μm (page 33).
Regarding claims 10-11, modified Chreene teaches the method of claim 1 as stated above. Niinomi teaches that “thermal debinding was performed from room temperature to 703 K in reduced pressure with argon gas current, and continuous sintering was performed in vacuum (10 2 Pa order) at various temperatures for 14.4 ks, followed by furnace cooling” (page 40). Niinomi teaches that “the tensile strength of all the compacts increases with increasing sintering temperature, but it remains nearly constant with increasing sintering temperature above 1,200 ° C” (page 41).
Regarding claim 17, modified Chreene teaches the method of claim 1 as stated above. Niinomi teaches that “the shrinkage during sintering is in the range between 12 and 18 %” (page 28).
Regarding claims 19-20, modified Chreene teaches the method of claim 1 as stated above. Chreene teaches that “the two capture members 20 of the fixation component 14 are coupled together along the component axis, X, by a bolt 48 and an internally threaded receiving shaft 50” (paragraph [0024]). Chreene teaches that “each base 30 has an aperture 44 for receiving the bolt 48 and the shaft 50” (paragraph [0024]). Chreene teaches that “on the inner sides 70 of the bases 30, around the apertures 44, are ridges 52” (paragraph [0025]). Chreene teaches that “to fix the relative position of the capture members 20 about the component axis, X, the bolt 48 is tightened and the ridges of the two bases 30 engage to lock the capture members in position” (paragraph [0025]).
Claims 7 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Chreene et al. (US 20130226179 A1), and Niinomi et al., Advances in Metallic Biomaterials, chapter 2, Metal Injection Molding (MIM) Processing, DOI 10.1007/978-3-662-46842-5, 2015, as applied to claim 1 above, and further in view of Julien et al. (US 20120136400 A1).
Regarding claims 7 and 18, modified Chreene teaches the method of claim 1 as stated above. Chreene teaches that “each capture member 20 defines opposing grooves 22, 24 on opposite lateral sides 26, 28, respectively, of the capture member 20, and that the groove 24 is sized to capture a first element, for example, a bone pin 16, and the groove 22 is sized to capture a second element having a diameter greater than the diameter of the first element, for example, a rod 18, of the orthopedic fixation system” (paragraph [0020]).
Chreene is silent regarding wherein the mold is partially filled with the metal granules for heating at a fusion temperature and pressure and fabricating a further metal orthopedic clamp component in the same mold.
Julien is similarly concerned with producing medical components using MIM (metal injection molding) (paragraphs [0006]-[0007]). Julien teaches “an assembled component that is created through this method is generated by “overmolding” one sub-component over another, and that as used here, the term “overmolding” refers to a method of attaching two sub-components by partially or wholly molding a second sub-component over a first sub-component” (paragraph [0184]). Julien teaches “generating the green part for the first sub-component to be overmolded, inserting the green part within the mold of the second sub-component, joining the two sub-components together by overmolding the second sub-component over the first sub-component” (which reads upon “wherein the mold is partially filled with the metal granules for heating at a fusion temperature and pressure and fabricating a further metal orthopedic clamp component in the same mold”, as recited in the instant claim; paragraph [0186]). Julien teaches “performing co-debinding in order to remove the binder from the assembled component while the components are in physical communication with each other, and then sintering the assembled component to form the final part” (which reads upon “for heating at a fusion temperature and pressure, the metal clamp component and the further metal orthopedic clamp component being coupled together to form a clamp device”, as recited in the instant claims; paragraph [0186]). Julien teaches that “the medical component may be a surgical implant; such as a hip implant, or other orthopedic implant, or could also be a surgical tool or a cutting guide, among other possibilities” (paragraph [0232]). Julien teaches that “it may be seen that there is a need in the industry for an improved MIM processing method that alleviates, at least in part, the deficiencies associated with existing MIM manufacturing processes in order to make it easier to manufacture components having certain desired geometries” (paragraph [0006]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Chreene to include overmolding, as taught by Julien in order to make it easier to manufacture components having certain desired geometries.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Chreene et al. (US 20130226179 A1), and Niinomi et al., Advances in Metallic Biomaterials, chapter 2, Metal Injection Molding (MIM) Processing, DOI 10.1007/978-3-662-46842-5, 2015, as applied to claim 1 above, and further in view of Sivigny et al. (US 20100300437 A1).
Regarding claim 15, modified Chreene teaches the method of claim 1 as stated above.
Chreene is silent regarding draft angles.
Sivigny is similarly concerned with the use of metal powder injection molding MPIM to make medical devices (paragraph [0009]). Sivigny teaches that “MPIM is also advantageous in that it allows for the manufacture of such valve components of various complex shapes and configurations to desirably tight tolerances” (paragraph [0011]). Sivigny teaches that “once the feedstock is prepared, the procedure of injection into the mold in MPIM is similar to the injection of feedstock in plastic injection molding, and MPIM allows the prepared feedstock to be readily injection molded into very many different configurations, including small and intricate features” (paragraph [0051]). Sivigny teaches that “the molding presses used (e.g. with heated screw-feed injection systems) and the molds used (e.g. hot runner multi-cavity molds) are also similar to those used for standard plastic injection molding” (paragraph [0051]). Sivigny teaches that “the same rules of part and mold design also apply, with respect to such considerations as wall thicknesses and their consistency, draft angles, tooling parting lines, gas vents, injection gates, ejector pins, undercuts, shut-outs, etc.” (which reads upon “wherein one or more exterior surfaces of the metal orthopedic clamp component have a draft angle to facilitate removal from the mold”, as recited in the instant claim; paragraph [0051]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the mold of Chreene to use draft angles, as taught by Sivigny because such mold design rules from plastic injection molding also apply to metal injection molding.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Chreene et al. (US 20130226179 A1), and Niinomi et al., Advances in Metallic Biomaterials, chapter 2, Metal Injection Molding (MIM) Processing, DOI 10.1007/978-3-662-46842-5, 2015, as applied to claim 1 above, and further in view of Sivigny et al. (US 20100300437 A1) and Szeremeta et al. (US 20150197053 A1).
Regarding claim 16, modified Chreene teaches the method of claim 1 as stated above. Chreene teaches that “on the inner sides 70 of the bases 30, around the apertures 44, are ridges 52” (paragraph [0025]).
Chreene is silent regarding draft angles.
Sivigny is similarly concerned with the use of metal powder injection molding MPIM to make medical devices (paragraph [0009]). Sivigny teaches that “MPIM is also advantageous in that it allows for the manufacture of such valve components of various complex shapes and configurations to desirably tight tolerances” (paragraph [0011]). Sivigny teaches that “once the feedstock is prepared, the procedure of injection into the mold in MPIM is similar to the injection of feedstock in plastic injection molding, and MPIM allows the prepared feedstock to be readily injection molded into very many different configurations, including small and intricate features” (paragraph [0051]). Sivigny teaches that “the molding presses used (e.g. with heated screw-feed injection systems) and the molds used (e.g. hot runner multi-cavity molds) are also similar to those used for standard plastic injection molding” (paragraph [0051]). Sivigny teaches that “the same rules of part and mold design also apply, with respect to such considerations as wall thicknesses and their consistency, draft angles, tooling parting lines, gas vents, injection gates, ejector pins, undercuts, shut-outs, etc.” (which reads upon “wherein one or more exterior surfaces of the metal orthopedic clamp component have a draft angle to facilitate removal from the mold”, as recited in the instant claim; paragraph [0051]).
Sivigny is silent as to suggested or typical draft angles.
Szeremeta teaches that “the injection molding process imposes certain constrains on the manufacturing process such as uniform wall thickness, round corners, draft angles, and the like” (paragraph [0002]). Szeremeta teaches that “production of an injection molding part having “zero degree” draft angle is feasible with a multi-part (e.g., split) mold design, however, a part produced by such a split mold design will usually bear witness lines that are generally undesirable from a cosmetic point of view” (paragraph [0009]). Szeremeta teaches that “to properly release an injection-molded part from the molding tool, plastic parts are most often designed with a taper in the direction of mold movement, and that this taper is commonly referred as “draft” on engineering drawings of an injection molded part” (paragraph [0012]). Szeremeta teaches that “the sidewalls have been provided with a non-zero draft angle to facilitate ejection of the workpiece from the mold” (paragraph [0012]). Szeremeta teaches that “the sidewalls have been provided with a non-zero draft angle to facilitate ejection of the workpiece from the mold” (which reads upon “wherein the surrounding walls have a draft angle between 0.5 degrees to 1.5 degrees”, as recited in the instant claim; paragraph [0013]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the mold of Chreene to use draft angles of from ½ degree to 1.5 degrees, as taught by Sivigny and Szeremeta because mold design rules from plastic injection molding such as draft angles of from ½ degree to 1.5 degrees also apply to metal injection molding.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA JANSSEN whose telephone number is (571)272-5434. The examiner can normally be reached on Mon-Thurs 10-7 and alternating Fri 10-6.
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/REBECCA JANSSEN/Primary Examiner, Art Unit 1733