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 .
Applicant's submission filed on 9/29/25 has been entered. Claims 1-9 are currently pending examination, Claims 10-20 are withdrawn.
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.
Claim(s) 1, 4-5, and 7-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bales et al (US 2003/0108659; hereafter Bales) in view of Li et al (“An investigation of the reduction of TiO2 by Mg in H-2 atmosphere” Chemical Engineering Science 195 (2019) 484-493, available 9/27/18; hereafter Li), Yang et al (“Preparation of porous titanium by direct in-situ reduction of titanium sesquioxide”, Vacuum 157 (2018) 453-457; hereafter Yang), and Hansson et al (US 2011/0151026; hereafter Hansson).
Claim 1: Bales teaches a method of forming micro- and/or nano-structures on a titanium-containing surface of a device (see, for example, abstract), the method comprising:
exposing the titanium-containing surface of the device having an initial microstructure to an oxidizing environment at a first elevated temperature so as to form titanium dioxide scale on the titanium-containing surface (see, for example, [0030] [0045]);
exposing the titanium dioxide scale to a reducing agent comprising an alkaline earth or an alkali element in the form of a vapor, at a second elevated temperature so as to convert or partially convert the titanium dioxide scale into a composite scale comprising metallic titanium and a second oxide of the alkaline earth or alkali element (See, for example, [0044-0048]). But it does not explicitly provide associated exemplary time / temperature conditions, so it does not explicitly teach the second elevated temperature of about 700oC for about 10 minutes to one hour. Li teaches a method of reducing TiO2 by alkaline earth (such Ca or Mg) (see, for example, pg 484-485). Li further establishes wherein the temperature and duration of the reduction process are result effective variables, tailorable based on initial oxide condition and to achieve the desired outcome (see, for example, abstract, section 2.3, Fig 5, pg 489-490, Table 1, conclusion). Li further teaches reduction at an exemplary condition of about 700 (such as 710oC) for 1 hr (see, for example, Fig 5). Therefore it would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to have incorporated conduct the reducing agent exposure at a second elevated temperature of about 700oC for about 1 hr since temperature and time combinations including about 700oC (710oC) and 1 hr have been demonstrated in the art to predictably achieve reduction of TiO2 using a Mg source and / or since the temperature and duration condition of a reduction process is well recognized in the art to be result effective, thus discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art. In re Boesch, 617 F.2d 272, 276 (CCPA 1980).
Bales does not explicitly teach exposing the composite scale to a dissolution agent that selectively dissolves part or all of the second oxide so as to yield a porous surface layer comprising the metallic titanium. Yang teaches a method of enhancing the porosity of titanium articles produced by reduction of TiO2 (see, for example, pg 453). Yang similarly teaches performing reduction by exposing the titanium oxide to a reducing agent at elevated temperature (calciothermic reduction) which converts the titanium oxide into a composite comprising a calcium oxide and titanium (See, for example, pg 453-454). Yang teaches that the calcium oxide byproduct can be predictably removed by leaching, leading to the generation of more porous structures (see, for example, pg 453-454 and Fig 1). Therefore it would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to have incorporated exposing the composite scale to a dissolution agent that selectively dissolves part or all of the second oxide as it would predictably remove the by-product calcium oxide with the added benefit of enhancing the porosity of the remaining titanium.
Bales further teaches wherein its’ invention is designed for use in medial articles and devices, further implants, and wherein oxide / porous layer thickness can be controlled (See, for example, [0005], [0030], claims). But Bales in view of Yang do not explicitly teach the titania scale and resulting porous surface has a submicron thickness and the porous surface layer have a nanoscale roughness and contains nanoscale pores having an average diameter of about 1 nm to about 300 nm. Hansson is similarly directed to a method of forming titanium implants with structured surfaces (See , for example, abstract, [0058], [0070], [0094]). Hansson teaches forming its invention oxide by convention heating, and further teaches wherein oxide layers should possess a thickness of 100 nm or less since thicker layers are very brittle and further lead to cracking and peeling during long periods of implantation (see, for example, [0078], and [0105]). Hansson further teaches wherein the implant surfaces preferably possess nano- micro-roughness of an RMS roughness of less than 250 nm comprising pores having a diameter of less than 1 micron, as such a roughness scale would give a larger contact and attachment area between the implant and the bone tissue and provide a better mechanical retention and strength between the implant and bone (See, for example, [0094-0095]). Therefore it would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to have incorporated the titania scale and resulting porous surface at a submicron thickness and the porous surface layer have a nanoscale roughness (<= 250 RMS) and contains nanoscale pores having an average diameter of less than or equal to 1 micron since such a thickness serves predictably at enhancing contact and attachment area between the implant and the bone tissue and provide a better mechanical retention and strength between the implant and bone while preventing brittle behavior and avoiding cracking and peeling). Although such a pore diameter range is not explicitly about 1 to about 300 nm, it would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to have incorporated an average pore diameter within the claimed range since in 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, 191USPQ 90 (CCPA 1976).
Claim 4: Bales further teaches wherein alteration of the time and temperature of the first elevated temperature, associated with oxidation of the titanium controls the oxide thickness achieved (See, for example, [0030]). Bales further teaches an exemplary range of such temperature as 700oC to 900oC (See, for example, 0030]).
Claim 5: Bales further teaches the reducing agent is selected from the group consisting of magnesium, calcium, strontium, barium, lithium, sodium, potassium, and rubidium (see, for example, [0045]).
Claim 7: Bales further teaches wherein the reducing agent comprises magnesium vapor and the second oxide is magnesium oxide (see, for example, [0045], [0047-48]; when the species is clearly named, the species claim is anticipated no matter how many other species are additionally named. Ex parte A 17 USPQ2d 1716 (Bd. Pat. App. & Inter. 1990).
Claim 8: Bales further teaches wherein the oxidizing environment is an oxygen-bearing environment (pure oxygen or a mixture of oxygen and nitrogen) (see, for example, [0030]).
Claim 9: Bales further taches wherein the device is a biomedical implant device (see, for example, [0005-22], claim 1)
Claim(s) 2-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bales in view of Li, Yang, and Hansson as applied to claim 1 above, and further in view of Dinger et al (US 2005/0159812; hereafter Dinger).
Claims 2-3: Bales in view of Li, Yang, and Hansson teach the method of claim 1 above, and Bales teaches wherein the device can be a wide variety of implantable articles for medical applications (See, for example, [0005-0012]), but it does not explicitly teach wherein the device has a nonporous or porous surface. The examiner notes that such claimed states are mutually exclusive so inherently at least one of the two are present. Further Dinger teaches a method of preparing an implantable device (see, for example, abstract). Dinger further teaches wherein the implants are widely known to be porous wherein the surface includes internal and external surfaces, and the internal surfaces are defined by the porosity of the device or nonporous (fully dense) depending on the ultimate use, where porous surface articles promote tissue growth into the implant and accelerate integrated healing; while non porous / fully dense articles can provide improved mechanical strength (see, for example, [0009]). Therefore it would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to have incorporated a device that has a nonporous or porous surface and wherein the surface includes internal and external surfaces, and the internal surfaces are defined by the porosity of the device as the amount of porosity is readily known to be dictated by the articles ultimate use and as porous articles with porous surfaces promote tissue growth into the implant and accelerate integrated healing; while non porous / fully dense articles with such non-porous surfaces can provide improved mechanical strength.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bales in view of Li, Yang, and Hansson as applied to claim 4 above, and further in view of Axen et al (US 2015/0351874; hereafter Axen).
Claim 6: Bales in view of Li, Yang, and Hansson teach the method of claim 4 above wherein Bales has taught wherein alteration of the first elevated temperature, associated with oxidation of the titanium, controls the oxide thickness achieved (See, for example, [0030]). Bales does not explicitly teach the temperature is about 600oC. Axen teaches a method of preparing Ti-containing implants (See, for example, abstract). Axen further is concerned with the thermal oxidation of such Ti-containing implants to form an oxidation layer thereon (See, for example, abstract, [0042-0043]). Axen further teaches wherein oxidation can be performed at temperatures below 700oC, further below 600oC, further, above 300oC, further 300oC -600oC, and wherein such lower temperatures can prevent uncontrolled oxidation ensuring control over the desired amount of oxidation (See, for example, [0043], [0055], [0057-0058]). Therefore it would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to have incorporated a temperature of about 300oC -600oC for oxidation since it would predictably prevent uncontrolled oxidation ensuring control over the desired amount of oxidation. Although such a range is not explicitly about 600oC, it would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to have incorporated a temperature within the claimed range since in 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, 191USPQ 90 (CCPA 1976), and/ or since discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art. In re Boesch, 617 F.2d 272, 276 (CCPA 1980).
Response to Arguments
Applicant’s amendments to claim 6, with respect to the previously applied 35 USC 112 a rejection of claim 6 have been fully considered and are persuasive; therefore this previously applied grounds or rejection has been withdrawn.
Applicant’s arguments that the references do not teach the newly added limitations are unconvincing in view of newly-cited Li, and further Axen, as discussed in the rejections above.
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.
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/NATHAN H EMPIE/Primary Examiner, Art Unit 1712