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
Claims 13-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 20 February 2026.
Response to Amendment
The amendment filed 01 July 2026 has been entered.
Claims 1-3, 5-9, and 11-18 remain pending in the application wherein claims 17 and 18 are new, claims 4 and 10 were previously canceled, and claims 13-16 are withdrawn.
The limitations in new claim 17 are found in the instant specification in paragraph 0011 (regarding XPS) and paragraph 0018 (regarding eluted amount). Limitations in new claim 18 are found in paragraph 0009. Accordingly, no new matter has been presented as a result of the amendments.
Response to Arguments
Applicant's arguments filed 01 July 2026 have been fully considered but they are not persuasive for the following reasons:
Applicant argues, see p. 5, that no evidence was provided to support that the manufacturing processes of Petersson, necessarily satisfy the limitations of the XPS peak area ratio and fluorine elution amount. However, the manufacturing process is not a claimed feature, and Applicant’s disclosure attributes the reduced elution of fluorine to an increased abundance of the second compound (i.e. the compound of titanium, oxygen, and fluorine) over the first compound (i.e. the compound of titanium and fluorine) (paragraph 0009 of the instant specification). The disclosure does not suggest that other methods of forming the second compound would not result in the recited properties. Furthermore, it is noted that Petersson specifically teaches ion implantation as one of the methods for providing fluorine/fluoride (paragraphs 0077-0082), provision of an oxide layer on the metallic implant surface that is more reactive than an oxide layer without fluorine/fluoride (i.e. the oxide layer with fluorine is considered to have the instantly claimed second compound including titanium, fluorine, and oxygen) (paragraph 0076), and that the fluorine and/or fluoride is preferably incorporated within the oxide layer (i.e. titanium oxide layer) on the metallic implant surface (paragraph 0076) (i.e. one would expect a considerably higher proportion of Ti-O-F compound over Ti-F compounds since fluorine/fluoride implantation is into a surface made of titanium oxide). That is, Petersson specifically teaches the argued process and the argued compound (i.e. including titanium, fluorine, and oxygen) with a fluorine concentration lower than that of the instant application (as outlined below). The courts have held that a reference that clearly names a species (i.e. the process, the compound, and the concentration) anticipates the claim and therefore the unexpected properties (i.e. measuring the ratio and elution amount) are immaterial. See MPEP § 2131.02(II); In re Sivaramakrishnan, 673 F.2d 1383, 213 USPQ 441 (CCPA 1982). Furthermore, the instant disclosure is not limited to ion-implantation (see paragraph 0021 of the instant specification).
Applicant argues, see p. 6, that Comparative Example 1 demonstrates merely introducing fluorine into titanium does not necessarily result in the instantly claimed XPS peak ratio area and fluorine elution amount. However, it is noted that Comparative Example 1 has a higher fluorine content than Example 1 of the instant disclosure. Since Comparative Example 1 was produced in the same manner as Example 1 except at a higher implantation dose (paragraphs 0043-0044 of the instant specification), then the comparison of these examples show a dependence on implantation dose (i.e. amount of fluorine). It is noted that the fluorine content calculated for the implant of Petersson is lower than the content for either Example 1 or Comparative Example 1. Example 2 of the instant disclosure differs from Example 1 and Comparative Example 1 inasmuch as the titanium substrate is first oxidized (i.e. has a surface layer of titanium oxide) and also that the titanium is titanium alloy instead of pure titanium (paragraph 0043-0044 and 0056 of the instant specification). Comparison of Example 2 with Comparative Example 1 (i.e. these two examples have substantially identical fluorine content) shows a dependence of fluorine elution on a surface that has been oxidized and/or on the presence of additional elements in the titanium substrate. However, comparison of Comparative Example 2 and Example 3 (paragraphs 0061-0062 of the instant specification; both made with pure titanium and substantially identical fluorine ion implantation but Example 3 was further subjected to oxidation treatment) confirms the dependence of fluorine elution on an oxidized surface. In this respect, it is noted that Petersson teaches a titanium implant surface (paragraph 0074) provided with fluorine and/or fluoride on at least a part of the implant surface (paragraph 0069) that is preferably incorporated within the oxide layer (i.e. titanium oxide layer; i.e. a surface layer located on a surface of the base material) on the metallic implant surface (paragraph 0076).
Applicant argues, see p. 6, that slight changes in manufacturing process conditions have a significant impact on the composition ratio and elution behavior. However, this argument lacks objective evidence. See MPEP § 2145(I).
Applicant further argues, see p. 6, that Petersson does not disclose the ratio of these compounds quantitatively using XPS. However, as outlined in the rejection below and in the arguments above, Petersson teaches a substantially identical titanium implant and therefore the resulting ratio and elution are considered to be present because a substantially identical material has substantially identical properties and functions. See MPEP § 2112.01. Furthermore, the courts have held that the discovery of a previously unappreciated property of a prior art composition does not render the old composition patentably new to the discoverer and that such feature need not be recognized at the relevant time. See MPEP § 2112(I and II).
Regarding claims 5 and 7, Applicant argues, see p. 6-7, a comparison of Example 1 to Comparative Example 1 as demonstrating that the range of the instantly claimed XPS peak area ratio is of critical significance. However, it is noted that, as outlined above, a comparison of the Examples to Comparative Examples demonstrate a dependence of elution on implantation dose (i.e. fluorine area concentration) and oxidation of the titanium surface (i.e. which would result in Ti-O-F compounds). Although the instant application quantifies these values, there is no evidence that the titanium implant of Petersson does not have these values in view of the fluorine area concentration and providing a titanium oxide layer at the surface.
Applicant further argues, see p. 7, that Petersson does not teach a relationship between a specific XPS peak area ratio and fluorine elution amount, antibacterial properties, or coexistence of low elution and high antibacterial properties. However, these features are not claimed. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See MPEP § 2145(VI). Furthermore, although a showing of criticality is to be considered when considering obviousness, Applicant has not demonstrated that the instantly claimed limitations (i.e. maximum fluorine concentration and surface layer thickness) are critical to these features (i.e. the aforementioned relationship, antibacterial properties, or coexistence). See MPEP § 2144.05(III)(A).
Claim Interpretation
The use of parentheses may introduce indefiniteness in a claim. However, the parentheses in claim 1 are considered to define XPS as the conventional abbreviation used for X-ray Photoelectron Spectrometry and the parentheses in claims 2 and 3 are considered to define the value of X (i.e. as a required feature of the claims).
Claim Rejections - 35 USC § 102
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, 6, 8-9, 11-12, and 17-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Petersson et al. (US 2006/0154206, previously cited).
Claim 1: Petersson teaches an implant treated to improve the biocompatibility (paragraph 0001). The implant surface is preferably a metallic implant surface such as a titanium implant surface (i.e. a base material of titanium) (paragraph 0074) provided with fluorine and/or fluoride on at least a part of the implant surface (paragraph 0069) that is preferably incorporated within the oxide layer (i.e. titanium oxide layer; i.e. a surface layer located on a surface of the base material) on the metallic implant surface (paragraph 0076). The fluorine/fluoride can be provided by any suitable method such as plasma deposition, electrochemical treatment, treatment with a solution containing fluorine/fluoride, ion implantation, etc. (paragraphs 0077-0082), and the fluorine/ fluoride is considered to form a titanium fluoride compound (i.e. a first compound including titanium and fluorine) (paragraph 0018), and provides an oxide layer on the metallic implant surface that is more reactive than an oxide layer without fluorine/fluoride (i.e. the oxide layer with fluorine is considered to have a second compound including titanium, fluorine, and oxygen) (paragraph 0076). The amount of fluorine/fluoride can decrease during storage (paragraph 0073) and the thickness of the oxide layer (i.e. amount of oxygen) increases with storage time (paragraph 0160) (i.e. over time the amount of second compound increases and amount of first compound decreases). Preferably the implant surface has an average atomic concentration of at least 0.2 at% fluorine and/or fluoride and ≤20 at%, preferably 0.4-7 at% (paragraphs 0071-0073). Based on a theoretical density of titanium dioxide (i.e. rutile form has a density of 4.23-4.26 g/cm3 which is slightly higher than the anatase or other crystal forms of titanium dioxide; calculations were made using the highest density of 4.26 g/cm3) and the molar weight of titanium dioxide (i.e. about 79.87 g/mol), the number of molecules at the surface is less than about 1.01x1015/cm2, which is equates about 2.02x1012/cm2 of fluorine and/or fluoride (i.e. lower for a porous oxide layer, higher for a higher concentration of fluorine/fluoride). The instantly claimed abundance of first compound relative to second compound, ratio of peak areas attributed to the first and second compounds, and amount of fluorine eluted are considered to be present because the range for amount of fluorine lies within the amount of the instant disclosure (i.e. compared to implanting 3x1017 atoms/cm2 or less of fluorine as disclosed in paragraph 0021 of the instant specification) and substantially identical materials have substantially identical properties and functions. See MPEP § 2112.01.
Claim 2: Petersson teaches that the fluorine and/or fluoride is preferably incorporated within the oxide layer (i.e. titanium oxide layer) on the metallic implant surface (paragraph 0076), which is considered to teach the second compound being at least one of the recited group as these are the different compounds and arrangements that can result from fluorine and/or fluoride incorporating into titanium oxide (e.g. at least fluorine-interstitial and/or fluorine substituted TiO2).
Claim 3: Petersson teaches that the fluorine/ fluoride is considered to form a titanium fluoride compound (i.e. a first compound including titanium and fluorine) (paragraph 0018), which would correspond to the instantly claimed first compound of TiFx wherein 1≤x≤4.
Claim 6: Petersson teaches that the implant surface has an average atomic concentration of at least 0.2 at% fluorine and/or fluoride and ≤20 at%, preferably 0.4-7 at% (paragraphs 0071-0073), which lies within the instantly claimed range. See MPEP § 2131.03.
Claim 8: Petersson teaches that the implant surface has an average atomic concentration of at least 0.2 at% fluorine and/or fluoride and ≤20 at%, preferably 0.4-7 at% (paragraphs 0071-0073). With such a low percentage of fluorine and/or fluoride, it would be reasonable for one of ordinary skill in the art to expect that not all of the titanium dioxide has fluorine/fluoride bonded thereto (i.e. there exists in the layer a third compound of titanium and oxygen).
Claim 9: Petersson teaches that the oxide layers of titanium implants mainly contain titanium(IV) dioxide (i.e. TiO2) (paragraph 0014).
Claim 11: Petersson teaches the implant surface (i.e. the base material) is preferably a metallic implant surface, such as a titanium implant surface (paragraph 0074), and is preferably made of commercially pure titanium or an alloy of titanium (paragraph 0094).
Claim 12: Petersson teaches an implant (i.e. the composite material as outlined above regarding claim 1) for implantation into bone tissue and treating the implant to improve the biocompatibility (i.e. a biocompatible implant) (paragraph 0001).
Claim 17: As outlined above regarding claim 1, Petersson teaches a substantially identical material, and substantially identical materials have substantially identical properties and functions. See MPEP § 2112.01.
Claim 19: As the first and second compounds of the titanium implant taught by Petersson (as outlined above) are substantially identical to the instantly claimed first compound and second compound, then the corresponding elution properties (i.e. the first compound being more easily eluted than the second compound) is also considered to be present.
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 5 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Petersson et al. (US 2006/0154206, previously cited) as applied to claim 1 above.
Claim 5: The teachings of Petersson regarding claim 1 are outlined above. Petersson teaches an implant treated to improve the biocompatibility (paragraph 0001), wherein the implant surface is preferably a metallic implant surface such as a titanium implant surface (paragraph 0074) provided with fluorine and/or fluoride on at least a part of the implant surface (paragraph 0069) that is preferably incorporated within the oxide on the metallic implant surface (paragraph 0076). The fluorine/fluoride can be provided by any suitable method such as plasma deposition, electrochemical treatment, treatment with a solution containing fluorine/fluoride, ion implantation, etc. (paragraphs 0077-0082), and the fluorine/ fluoride is considered to form a titanium fluoride compound (i.e. a first compound including titanium and fluorine) (paragraph 0018), and provides an oxide layer on the metallic implant surface that is more reactive than an oxide layer without fluorine/fluoride (i.e. the oxide layer with fluorine is considered to have a second compound including titanium, fluorine, and oxygen) (paragraph 0076). The amount of fluorine/fluoride can decrease during storage (paragraph 0073) and the thickness of the oxide layer (i.e. amount of oxygen) increases with storage time (paragraph 0160) (i.e. over time the amount of second compound increases and amount of first compound decreases). Preferably the implant surface has an average atomic concentration of at least 0.2 at% fluorine and/or fluoride and ≤20 at% (paragraphs 0071-0073), which overlaps the instantly claimed range. 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 no demonstration of a criticality to the claimed ranges has been presented.
While not reciting a singular example of the instantly claimed composite material (e.g. having a maximum value of fluorine concentration that exceeds 10 atom%), it would have been obvious to one of ordinary skill in the art before the effective filing date because the amount of fluorine overlaps the instantly claimed range and the courts have held overlapping ranges to be prima facie obvious. See MPEP § 2144.05.
Claim 7: Petersson teaches that the titanium oxide layer of implants generally has a thickness of about 4-8 nm, but can be up to about 20 µm (i.e. about 20,000 nm) by using anodic oxidation (paragraph 0014). This thickness overlaps the instantly claimed thickness. See MPEP § 2144.05.
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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/KIM S. HORGER/Examiner, Art Unit 1784
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