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 1-8 and 16-20, in the reply filed on 04 November 2025 is acknowledged.
The requirement is still deemed proper and is therefore made FINAL.
Claims 9-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04 November 2025.
Claim Interpretation
The limitations of a “first curve” and a “measurement length” as recited in instant claim 2 are considered to refer to the outer circumferential surface of the implant body as schematically indicated below wherein the first curve is a length obtained while following the surface profile of peaks and valleys and wherein the measurement length is a reference standard that does not take into account surface profile.
[AltContent: connector][AltContent: textbox (Measurement length)][AltContent: textbox (First curve (the length if this line was stretched out flat))]
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.
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.
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.
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 1-4, 6-8, 16-17, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Gallagher et al. (US 2019/0231535).
Claim 1: Gallagher teaches metal surfaces for orthopedic implants that stimulate cells upon implantation within the body to facilitate new bone growth (paragraph 0002) (i.e. a biological implant implantable in a base being apart a part of a living organism). One or more of the surfaces can be mechanically and chemically eroded to impart osteoinducting roughness comprising micro-scale structures and nano-scale structures (paragraph 0006). The orthopedic implant includes the engineering and designing of the geometry, dimensions, and structural feature of the implant body and may have any suitable shape or geometry and any suitable number of sides and surfaces, such as flat, round, regular and/or irregular surfaces, and may be a joint replacement, a bone replacement, an implant to induce joining of separate bones, an implant to fasten another implant to a bone or facilitate rejoinder of broken bones such as nails, screws, rods, etc. (i.e. at least nails, screws, and rods have an outer circumferential surface) (paragraph 0046). The orthopedic implant may be any suitable material, with metals being highly preferred and preferred metals include titanium and titanium alloys (paragraph 0049). Gallagher does not specifically teach the instantly claimed method of measuring the arithmetic mean roughness (filtered at a cutoff value of 5 µm); however, optimizing the roughness would have been obvious to one of ordinary skill in the art because Gallagher teaches that mechanical and chemical erosion add the micro-scale and nano-scale structures respectively (i.e. surface roughness at different scale levels) to the bone-contacting surfaces and these different scale roughness at least partially overlap, or substantially overlap, or may completely overlap, to significantly enhance one or more of stem cell differentiation, preosteoblast maturation, osteoblast development, osteoinduction, and osteogenesis (paragraph 0097). Furthermore, Gallagher teaches that the micro-scale structural features (i.e. roughness) includes dimensions measured in microns such as 1 micron or greater but less than 1 mm, and nano-scale structural features include dimensions that are measures in nanometers such as 1 nanometer or greater but less than 1 micron, and these dimensions overlap the instantly claimed surface roughness (i.e. even when considering only dimensions smaller than 5 µm; i.e. the average roughness, or surface feature variance, would be due to the presence of micron-scale features and nano-scale features). The courts have held that a prima facie case of obviousness exists where claimed ranges overlap, lie inside of, or are close to ranges in the prior art. See MPEP § 2144.05. It is noted that as of the writing of this Office Action, no demonstration of a criticality to the claimed ranges has been presented.
While not reciting a singular example of the instantly claimed biological implant, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the orthopedic implant of Gallagher to include the instantly claimed arithmetic mean roughness of the outer circumferential surface (i.e. a bone-contacting surface), and one would have had a reasonable expectation of success.
Claim 2: Gallagher teaches metal surfaces for orthopedic implants that stimulate cells upon implantation within the body to facilitate new bone growth (paragraph 0002) (i.e. a biological implant implantable in a base being apart a part of a living organism). One or more of the surfaces can be mechanically and chemically eroded to impart osteoinducting roughness comprising micro-scale structures and nano-scale structures (paragraph 0006). The orthopedic implant includes the engineering and designing of the geometry, dimensions, and structural feature of the implant body and may have any suitable shape or geometry and any suitable number of sides and surfaces, such as flat, round, regular and/or irregular surfaces, and may be a joint replacement, a bone replacement, an implant to induce joining of separate bones, an implant to fasten another implant to a bone or facilitate rejoinder of broken bones such as nails, screws, rods, etc. (i.e. at least nails, screws, and rods have an outer circumferential surface) (paragraph 0046). The orthopedic implant may be any suitable material, with metals being highly preferred and preferred metals include titanium and titanium alloys (paragraph 0049). Gallagher does not specifically teach the instantly claimed ratio of first curve to measurement length (i.e. appears to be a manner of measuring surface roughness). however, optimizing the roughness would have been obvious to one of ordinary skill in the art because Gallagher teaches that mechanical and chemical erosion add the micro-scale and nano-scale structures respectively (i.e. surface roughness at different scale levels) to the bone-contacting surfaces and these different scale roughness at least partially overlap, or substantially overlap, or may completely overlap, to significantly enhance one or more of stem cell differentiation, preosteoblast maturation, osteoblast development, osteoinduction, and osteogenesis (paragraph 0097). Furthermore, Gallagher teaches that the micro-scale structural features (i.e. roughness) includes dimensions measured in microns such as 1 micron or greater but less than 1 mm, and nano-scale structural features include dimensions that are measures in nanometers such as 1 nanometer or greater but less than 1 micron. The length of the profile surface features corresponding to a first curve would be greater than a measurement length of 25.4 µm, due to the presence of micron-scale features and nano-scale features, which overlaps the instantly claimed ratio. The courts have held that a prima facie case of obviousness exists where claimed ranges overlap, lie inside of, or are close to ranges in the prior art. See MPEP § 2144.05. It is noted that as of the writing of this Office Action, no demonstration of a criticality to the claimed ranges has been presented.
While not reciting a singular example of the instantly claimed biological implant, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the orthopedic implant of Gallagher to include the instantly claimed ratio (i.e. as an indication of surface roughness) for the outer circumferential surface (i.e. a bone-contacting surface), and one would have had a reasonable expectation of success.
Claims 3 and 16: Gallagher teaches that alloys of titanium are used for medical implants (paragraph 0068), wherein Ti-6Al-4V is the most common titanium alloy (paragraph 0074), with the higher-purity version (i.e. Ti-6Al-4V ELI) having excellent biocompatibility and with common applications include joint replacements, bone fixation devices, surgical clips, etc. (paragraph 0075). Ti-6Al-4V ELI is an alpha-beta alloy (i.e. an α-β-alloy) (paragraph 0075).
Claims 4 and 17: Gallagher teaches that alloys of titanium are used for medical implants (paragraph 0068), wherein Ti-6Al-4V (i.e. a titanium-6 aluminum-4 vanadium alloy) is the most common titanium alloy (paragraph 0074), with the higher-purity version (i.e. Ti-6Al-4V ELI) having excellent biocompatibility and with common applications include joint replacements, bone fixation devices, surgical clips, etc. (paragraph 0075).
Claim 6: Gallagher does not specifically teach the instantly claimed method of measuring the arithmetic mean roughness (filtered at a cutoff value of 5 µm); however, optimizing the roughness would have been obvious to one of ordinary skill in the art because Gallagher teaches that mechanical and chemical erosion add the micro-scale and nano-scale structures respectively (i.e. surface roughness at different scale levels) to the bone-contacting surfaces and these different scale roughness at least partially overlap, or substantially overlap, or may completely overlap, to significantly enhance one or more of stem cell differentiation, preosteoblast maturation, osteoblast development, osteoinduction, and osteogenesis (paragraph 0097). Furthermore, Gallagher teaches that the micro-scale structural features (i.e. roughness) includes dimensions measured in microns such as 1 micron or greater but less than 1 mm, and nano-scale structural features include dimensions that are measures in nanometers such as 1 nanometer or greater but less than 1 micron, and these dimensions overlap the instantly claimed surface roughness (i.e. even when considering only dimensions smaller than 5 µm; i.e. the average roughness, or surface feature variance, would be due to the presence of micron-scale features and nano-scale features). The courts have held that a prima facie case of obviousness exists where claimed ranges overlap, lie inside of, or are close to ranges in the prior art. See MPEP § 2144.05. It is noted that as of the writing of this Office Action, no demonstration of a criticality to the claimed ranges has been presented.
Claims 7 and 19: Gallagher teaches orthopedic implant includes the engineering and designing of the geometry, dimensions, and structural feature of the implant body and may have any suitable shape or geometry and any suitable number of sides and surfaces, such as flat, round, regular and/or irregular surfaces, and may be a joint replacement, a bone replacement, an implant to induce joining of separate bones, an implant to fasten another implant to a bone or facilitate rejoinder of broken bones such as nails, screws, rods, etc. (i.e. at least nails, screws, and rods have an outer circumferential surface) (paragraph 0046). That is, being a porous structure is considered to be a change of shape and is obvious as a matter of design choice. See MPEP § 2144.04(IV)(B). Gallagher further teaches that bone-contacting surfaces and free surfaces can be subjected to mechanical and/or chemical erosion and thus include a macro-scale roughness, a micro-scale roughness, and a nano-scale roughness (paragraph 0097). For a porous structure, free surfaces would include any inner surfaces, so having a macro-scale roughness, a micro-scale roughness, and a nano-scale roughness would include having an arithmetic mean roughness value that overlaps the instantly claimed range for the same reasons outlined above regarding claim 1.
Claims 8 and 20: Gallagher teaches the orthopedic implant may be a joint replacement, a bone replacement, an implant to induce joining of separate bones, an implant to fasten another implant to a bone or facilitate rejoinder of broken bones such as nails, screws, rods, etc., an implant for replacing an intervertebral disc or spinal motion segment (i.e. a spinal implant) (paragraph 0046).
Claims 5 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Gallagher et al. (US 2019/0231535) as applied to claims 1 and 2 above, and further in view of Ishimizu et al. (US 2014/0335370).
Claims 5 and 18: The teachings of Gallagher regarding claims 1 and 2 are outlined above. Gallagher teaches metal surfaces for orthopedic implants that stimulate cells upon implantation within the body to facilitate new bone growth (paragraph 0002). The orthopedic implant includes the engineering and designing of the geometry, dimensions, and structural feature of the implant body and may have any suitable shape or geometry and any suitable number of sides and surfaces, such as flat, round, regular and/or irregular surfaces, and may be a joint replacement, a bone replacement, an implant to induce joining of separate bones, an implant to fasten another implant to a bone or facilitate rejoinder of broken bones such as nails, screws, rods, etc. (paragraph 0046). The orthopedic implant may be any suitable material, with metals being highly preferred and preferred metals include titanium and titanium alloys (paragraph 0049) with a higher-purity version of Ti-6Al-4V having excellent biocompatibility and therefor being the material of choice (paragraph 075). Gallagher further teaches that additions of columbium (i.e. niobium) and tantalum produce improved strength and help in preventing embrittlement produced by the presence of compounds of titanium and aluminum (paragraph 0071). However, Gallagher does not teach specifically the instantly claimed titanium alloy of titanium-6 aluminum-7 niobium alloy or titanium-6 aluminum-2-niobium-1 tantalum alloy.
In a related field of endeavor, Ishimizu teaches implant materials such as an artificial bone, artificial joint, or artificial dental root (i.e. a dental implant) to be embedded and used in a living body are required to be excellent in compatibility with biotissues (paragraph 0002). Ishimizu teaches that open holes are formed in terms of retention of compatibility with a living body (paragraph 0015) and a porosity of holes in the living body side may be set in consideration of compatibility with the living body to typically 50-85% (i.e. the implant includes a porous structure) (paragraph 0024). Metals that may be used include, for example, Ti alloys such as Ti-6Al-4V, Ti-6Al-2Nb-1Ta (i.e. titanium-6 aluminum-2 niobium- 1 tantalum alloy), etc. (paragraph 0025).
As Ishimizu and Gallagher both teach an implant such as artificial bone or joint made of titanium alloy, they are analogous. It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the implant of Gallagher to include where the titanium alloy may be Ti-6Al-2Nb-1Ta as a known alternative to Ti-6Al-4V for an implant material, and one would have had a reasonable expectation of success.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Ishiai et al. (US 2013/0013082) teaches a metal material for a bioimplant that has been surface roughened to improve integration to a bone (paragraph 0002). The implant may be a dental implant, artificial joint, artificial bone, etc. (paragraph 0017). The metal material may be a titanium alloy such as Ti-6Al-4V, Ti-6Al-2Nb-1Ta0.8Mo, etc. (paragraph 0035). The average roughness Ra of the surface after surface roughening is about 1-2.5 µm (paragraph 0013).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KIM S HORGER whose telephone number is (571)270-5904. The examiner can normally be reached M-F 9:30 AM - 4:00 PM EST.
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/KIM S. HORGER/Examiner, Art Unit 1784