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 .
Response to Amendment
The amendment filed 21 May 2026 has been entered.
Claims 1 and 3-15 remain pending in the application, wherein claim 1 has been amended, claims 8-15 are withdrawn, and claims 2 and 16-20 are newly canceled..
Support for the amendments to claim 1 is found in paragraph 0045 of the instant specification. Accordingly, no new matter has been introduced by these amendments.
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, 3-4, and 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Gallagher et al. (US 2019/0231535, previously cited).
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 (i.e. applying a Gaussian filter to the first curve at a cutoff value of 5 µm in image processing); 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 3: 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).
Claim 4: 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.
Claim 7: 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.
Claim 8: 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).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Gallagher et al. (US 2019/0231535, previously cited) as applied to claim 1 above, and further in view of Ishimizu et al. (US 2014/0335370, previously cited).
Claim 5: The teachings of Gallagher regarding claim 1 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.
Response to Arguments
Applicant's arguments filed 21 May 2026 have been fully considered but they are not persuasive. Applicant argues that Gallagher does not teach or render obvious the following limitations:
Regarding a “first curve” indicating a profile of the outer circumferential surface: Gallagher teaches that 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). Because the orthopedic implant has an outer circumferential surface, then a first curve is necessarily present as the first curve is recited to be a profile of the outer circumferential surface (i.e. a surface necessarily has a profile).
Regarding a “second curve” derived from the first curve by applying a Gaussian filter in image processing: This is considered to be a product-by-process limitation, which is not limited to the manipulations of the recited steps, only the structure implied by the steps. See MPEP § 2113. As the second curve is obtained entirely by image processing, no new structural feature is introduced by this limitation.
Regarding the surface roughness value: Applicant argues that the surface roughness disclosed by Gallagher is not obtained by the instantly claimed metrology and image-processing protocol. However, this limitation is considered to be a product-by-process limitation, which is not limited to the manipulations of the recited steps, only the structure implied by the steps. See MPEP § 2113. As outlined above, Gallagher teaches an overlapping range for the surface roughness. See MPEP § 2144.05. Applicant has not provided a showing that the method of obtaining the surface roughness as claimed results in a significantly different surface roughness and has not demonstrated a criticality to the instantly claimed value of surface roughness.
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.
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
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