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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/19/2025 has been entered. The previous objection to the claims is withdrawn in light of applicant’s amendments. Claims 7-15 are currently pending in this application.
Response to Arguments
Applicant's arguments filed 11/19/2025 have been fully considered but they are not persuasive.
With regard to applicant’s argument that Oliveira does not teach phosphorous-based compounds on the surface, the examiner disagrees. Section 4. Discussion discloses an analysis of the influence of phosphorous content on the expression of osteopontin and that Oliveira observed that hydrophilic and phosphorous content on the surface can induce the osteopontin up-regulation, protein related to cell adhesion in early stages of in vitro tests.
With regard to applicant’s argument that Oliveira does not teach an increase in effective area as claimed, the examiner disagrees. See rejection of new claim 15 below.
With regard to applicant’s argument that there are major differences between Oliveira and the claimed invention, the examiner disagrees. The examiner maintains that Oliveira meets the limitations as claimed. See rejection below.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 7, 8, and 11-14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gene Expression of human osteoblasts cells on chemically treated surfaces of Ti-6Al-4V-ELI to Oliveira et al. (Oliveira).
Regarding claim 7
Oliveira teaches surface modifications of titanium alloys as useful methods to enhance the biological stability of intraosseous implants and to promote a well succeeded osseointegration in the early stages of implantation (abstract). Oliveira meets the limitations of a bioactive, osteoinductive, and osteoconductive surface of implants or scaffolds, wherein the surface is a three-dimensional engineering surface of the bodies of the implants or scaffolds, the surface comprising: a physically and chemically controlled and organized topography (the topography of Oliveira is disclosed to be obtained by alkaline treatments carried on the surfaces previously acid etched imparted a homogenous sponge-like structure on the surface, and is therefore construed to be physically and chemically controlled and organized; section 3.1, third paragraph) containing: a macroscopic topography, including smooth topography and/or macrometric surface structures, a microscopic topography is superimposed on the macroscopic topography, the microscopic topography including micrometric and/or submicrometric surface structures; and a nanoscopic topography is superimposed on the microscopic topography, the nanoscopic topography comprising nanoscopic surface structures containing nano characteristics and structures in fractal dimension, wherein one or more chemical species and/or chemical compounds are incorporated into the surface (page 252, sections 3.1 and 3.3, disclose a surface morphology of implants that includes macroscopic, smooth topography on which microscopic topography is superimposed and micrometric and/or submicrometric surface structures on which nanoscopic topography is superimposed via acid etching combined with alkaline treatment; section 3.1 further discloses that the alkaline treatments on the previously acid etched surfaces impart a sponge-like structure which contains nano characteristics and structures in fractal dimension, in the same way as applicant’s as disclosed in paragraph 046 with regard to the structure similar to coral of the seabed; section 3.2 also discloses one or more chemical species and/or chemical compounds, i.e. oxygen, sodium, calcium, incorporated into the surface), wherein the surface forms micro-coral-like topography (page 252, sections 3.1 and 3.3, disclose a surface morphology of implants that includes macroscopic, smooth topography on which microscopic topography is superimposed and micrometric and/or submicrometric surface structures on which nanoscopic topography is superimposed via acid etching combined with alkaline treatment; section 3.1 further discloses a sponge-like structure/topography which contains nano characteristics and structures in fractal dimension; section 4 on page 253 also discloses induction of osteopontin up-regulation, protein related to cell adhesion – the surface described by Oliveira is therefore construed to be micro-coral-like in the same way as applicant’s as disclosed in paragraph 046 because it is composed of micro and nano topography and favors the adhesion of cells) and is configured to attract, absorb, and incorporate bio-ions and molecules (page 253, Section 4. Discussion discloses inducing up-regulation of osteopontin, protein related to cell adhesion, which is an example of a molecule, and page 254, col. 1, discloses a Ca2+ binding glycoprotein, which is an example of a bio-ion).
Regarding claim 8
Oliveira teaches the bioactive, osteoinductive and osteoconductive surface of implants or scaffolds of claim 7, wherein said body is made of a metal or metal alloy, where the macroscopic topography is obtained by conformation, and/or subtraction, and/or deposition of material with a peak-to-valley roughness parameter Rz and an areal maximum height parameter Sz, between 1000 to 0 micrometers (µm) (page 249, col. 2, section 2.1 discloses a body made of a metal or metal alloy, where the macroscopic topography is obtained by acid etching with a peak-to-valley roughness and an areal maximum height parameter between 1000 to 0 micrometers).
Regarding claim 11
Oliveira teaches the bioactive, osteoinductive and osteoconductive surface of implants or scaffolds of claim 7, further comprising bioactive properties related to bone tissue (page 248 discloses that the processes for surface modification aim to control the cells activities, for example, adhesion, spreading and gene expression of osteoblasts in a way to accelerate the bone mineralization onto the surface and promote biological stability and therefore comprise bioactive properties related to bone tissue), hydrophilic properties with dynamic contact angles below 90 degrees (page 253, section 3.4 and Fig. 6 show that the surface comprises hydrophilic properties with dynamic contact angles below 90 degrees); properties of high cell attraction and adhesion, in which the cells are part of the group consisting of multipotent cells, human mesenchymal stem cells, pre-osteoblastic cells, osteoblastic cells, osteocytes, osteoclasts, fibroblasts, red blood cells, leukocytes, platelets and monocytes (page 253, section 3.5 discloses osteoblastic cells); control of dynamics of cellular gene expression, in which the genes are part of the group of genes that control the osteoinduction process, osteoconduction process and osteogenic process, with osteoconductive and osteoinductive properties (pages 248-249 discloses that the processes for surface modification controls gene expression of osteoblasts in a way to accelerate the bone mineralization onto the surface and promote biological stability and therefore controls dynamics of cellular gene expression of bone-related proteins to control the osteoinduction and osteogenic processes with osteoinductive properties; page 251, section 2.3.4 discloses genes that control, osteoconduction with osteoconductive properties).
Regarding claim 12
Oliveira also meets the limitations of a method of making the bioactive, osteoinductive and osteoconductive surface of implants or scaffolds of claim 7 (see rejection of claim 7 above), comprising: surface treatment of bodies comprising metals and/or metal alloys (page 249, col. 2, section 2.1 discloses a body made of a metal or metal alloy) by processing to obtain a physically and chemically controlled and organized three-dimensional engineering surface, in macro, micro and nanoscale (page 252, section 3.1, discloses processing to obtain a controlled and organized surface in macro, micro, and nanoscale), through the following actions: surface modification for the formation of a topography on a macroscopic scale by conformation and/or subtraction processing and/or addition of material in the surface of the bodies (section 2.1 discloses wet-abrading the metal body to simulate a machined-turned surface); cleaning the surface for the removal of any type of undesirable residue (section 2.1, discloses immersion in deionized water); modifying the surface for the formation of a topography on a microscopic and/or submicroscopic scale through chemical treatment and/or electrochemical treatment (section 2.1 discloses acid etching); cleaning the surface for the removal of any undesirable residue (section 2.1, discloses immersion in deionized water); modifying the surface for the formation of a topography on a nanoscopic scale carried out through chemical treatment and/or electrochemical treatment (section 2.1 discloses alkaline treatment); cleaning surface cleaned for the removal of any undesirable residue (section 2.1 discloses immersion in deionized water); incorporating chemical species into the surface (page 252, section 3.2, discloses incorporation of chemical species and compounds on the surface); washing and cleaning the surface in deionized water, drying the surface and sterilizing the surface (section 2.1, discloses immersion in deionized water, heating/drying, and sterilization with gamma radiation).
Regarding claim 13
Oliveira teaches the bioactive, osteoinductive and osteoconductive surface of implants or scaffolds of claim 7, wherein the surface is configured to attract, absorb, and incorporate of bio- ions selected from the group consisting of K+, Ca2+,Sr2+, Mg2+, and PO42- (page 253, Section 4. Discussion discloses inducing protein related to cell adhesion in early stages and page 254, col. 1, discloses a Ca2+ binding glycoprotein).
Regarding claim 14
Oliveira teaches the bioactive, osteoinductive and osteoconductive surface of implants or scaffolds of claim 7, wherein the surface is configured to attract, absorb, and incorporate of molecules selected from the group consisting of osteopontin, actins, integrins, and osteocalcin (page 253, Section 4. Discussion discloses inducing up-regulation of osteopontin, protein related to cell adhesion).
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.
Claim(s) 9-10 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Oliveira.
Regarding claim 9
Oliveira teaches the bioactive, osteoinductive and osteoconductive surface of implants or scaffolds of claim 7, further comprising a microscopic topography including submicroscopic topography, with surface structures between 0 to 100 µm (page 249, col. 1, discloses imparting micro, submicro and nano features onto the surface and table 3 shows that the surface structures are between 1 and 100 microns), with controlled surface parameters (page 252 discloses surface parameters are controlled), including roughness parameters (as shown in Table 3 and Fig. 1).
However, Oliveira does not explicitly teach an arithmetic average roughness parameter Ra and an areal roughness parameter Sa between 0 to 100 µm; the peak-to-valley roughness parameter Rz and the areal maximum height parameter Sz between 0 to 100 µm; a skewness parameter Ssk from 1.0 to -1.0; and a kurtosis parameter Sku from 0 to 10; and a mean spacing of surface features parameter Sm between 0 and 250 µm.
Based on the roughness parameters taught by Oliveira, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the Oliveira surface to have an arithmetic average roughness parameter Ra and an areal roughness parameter Sa between 0 to 100 µm; the peak-to-valley roughness parameter Rz and the areal maximum height parameter Sz between 0 to 100 µm; a skewness parameter Ssk from 1.0 to -1.0; and a kurtosis parameter Sku from 0 to 10; and a mean spacing of surface features parameter Sm between 0 and 250 µm, as it involves only specifying arbitrary parameter ranges in a device that has the same structure as applicant’s. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the surface of Oliveira by making the arithmetic average roughness parameter Ra and areal roughness parameter Sa between 0 to 100 µm; the peak-to-valley roughness parameter Rz and the areal maximum height parameter Sz between 0 to 100 µm; a skewness parameter Ssk from 1.0 to -1.0; and a kurtosis parameter Sku from 0 to 10; and a mean spacing of surface features parameter Sm between 0 and 250 µm, as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 10
Oliveira teaches the bioactive, osteoinductive and osteoconductive surface of implants or scaffolds of claim 7, further comprising a nanoscopic topography with surface structures between 0 to 100 nm, with controlled surface parameters (page 49, col. 1, discloses nano features). Oliveira also teaches that the alkaline treatments on the previously acid etched surfaces impart a sponge-like structure which contains nano characteristics and structures in fractal dimension, in the same way as applicant’s as disclosed in paragraph 046 with regard to the structure similar to coral of the seabed (section 3.1).
However, Oliveira does not explicitly teach roughness with a arithmetic average roughness parameter Ra and a areal roughness parameter Sa between 0 to 1 µm; a peak-to-valley roughness parameter Rz and a areal maximum height parameter Sz between 0 to 1 µm; a skewness parameter Ssk from 1.0 to -1.0; and a kurtosis parameter Sku from 0 to 10; where the surface has a fractal dimension (Df) between 2 and 3, with structures of sizes less than 100 nm, regardless of the aspect ratio and shape of the structures, and with isotropic configuration.
Based on the roughness parameters taught by Oliveira, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the Oliveira surface to have a arithmetic average roughness parameter Ra and a areal roughness parameter Sa between 0 to 1 µm; a peak-to-valley roughness parameter Rz and a areal maximum height parameter Sz between 0 to 1 µm; a skewness parameter Ssk from 1.0 to -1.0; and a kurtosis parameter Sku from 0 to 10; where the surface has a fractal dimension (Df) between 2 and 3, with structures of sizes less than 100 nm, regardless of the aspect ratio and shape of the structures, and with isotropic configuration, as it involves only specifying apparently variable parameter ranges, dimensions and shapes in a device that has the same structure as applicant’s. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the surface of Oliveira by making the arithmetic average roughness parameter Ra and the areal roughness parameter Sa between 0 to 1 µm; the peak-to-valley roughness parameter Rz and the areal maximum height parameter Sz between 0 to 1 µm; the skewness parameter Ssk from 1.0 to -1.0; and the kurtosis parameter Sku from 0 to 10; where the surface has a fractal dimension (Df) between 2 and 3, with structures of sizes less than 100 nm, regardless of the aspect ratio and shape of the structures, and with isotropic configuration, as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 15
Oliveira teaches the method according to claim 12, including an increase of the effective surface areas, around 50% (page 252, Section 3.3 Roughness and surface area).
However, Oliveira does not explicitly teach wherein the surface has an effective increase in area ranging from 50% to 1000% after the surface treatment.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the increase of Oliveira from about 50% to between 50% and 1000% as applicant appears to have placed no criticality on the claimed range (see paragraph 049 indicating the object of the invention is a surface where the macroscopic topography is based on the surface area, the effective increase of area within the claimed range after procedures) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA A HOBAN whose telephone number is (571)270-5785. The examiner can normally be reached Monday-Friday 8:00AM-5:00PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at 571-272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.A.H/Examiner, Art Unit 3774
/BRIAN A DUKERT/Primary Examiner, Art Unit 3774