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, drawn to a method for the passivation of a surgical implant comprising titanium and the use of a solution comprising hydrochloric acid, sulfuric acid, and hydrogen peroxide for the passivation of a surgical implant comprising titanium, in the reply filed on 01/29/2026 is acknowledged.
Claim 13 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 01/29/2026.
Claims 1-12 and 14 are under current examination.
Priority
This application is a national stage entry of PCT/ES2023/070238, filed 04/17/2023.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 02/06/2024 and 08/12/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the Examiner.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 14 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim does not fall within at least one of the four categories of patent eligible subject matter because it is a “use” claim that does not claim a process, machine, manufacture, or composition of matter. Per MPEP 2173.05(q),"’Use’ claims that do not purport to claim a process, machine, manufacture, or composition of matter fail to comply with 35 U.S.C. 101. In re Moreton, 288 F.2d 708, 709, 129 USPQ 227, 228 (CCPA 1961)("one cannot claim a new use per se, because it is not among the categories of patentable inventions specified in 35 U.S.C. § 101 ").”
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 5-7, 11, and 14 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claims 5-7 recite concentrations with units “(v/v)”; the parentheses render the claims indefinite as to whether this limitation is required feature of the claim or not. If Applicant intends for these to be required limitations, it is recommended that the parentheses be removed.
Claim 11 recites “The method according to claim 1, wherein the washes of steps b) and c) have a duration between 1 min and 2 min”. It is unclear if Applicant intends to claim i) that each wash step has a duration between 1 min and 2 min, respectively, or ii) that the total duration of the combined washes of steps b) and c) is between 1 min and 2 min. For purposes of examination and applying prior art, it is interpreted that each wash step, respectively, has a duration between 1 min and 2 min.
Claim 14 recites a use, but fails to recite any active steps in the “use” claim, rendering the scope of the claim indefinite. From MPEP 2173.05(q): “Attempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. For example, a claim which read: "[a] process for using monoclonal antibodies of claim 4 to isolate and purify human fibroblast interferon" was held to be indefinite because it merely recites a use without any active, positive steps delimiting how this use is actually practiced. Ex parte Erlich, 3 USPQ2d 1011 (Bd. Pat. App. & Inter. 1986).”
Claim Rejections - 35 USC § 102
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.
Claims 1, 4-7, 9-10, 12, and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cruz et al. (“Relevant Aspects of Piranha Passivation in Ti6Al4V Alloy Dental Meshes” Coatings 2022, 12, 154; included on IDS submitted 02/06/2024) hereafter “Cruz”.
Regarding instant claim 1, Cruz teaches the passivation of titanium alloy dental meshes (see entire document, particularly abstract). Titanium meshes are used as medical implants for bone regeneration (see pg. 2-3, “Introduction”, particularly paragraph 3). Cruz teaches Piranha passivation of titanium alloy meshes wherein the meshes were immersed in a mixture of sulfuric acid and a 50:50 ratio of hydrochloric acid and hydrogen peroxide (pg. 3, “2.1. Samples”). The samples were cleaned with a sequence of 3 ultrasonic baths: two consecutive with distilled water, followed by one with ethanol (pg. 3, “2.1. Samples”).
Regarding instant claim 4, Cruz teaches immersion of the meshes in a mixture of sulfuric acid and a 50:50 ratio of hydrochloric acid and hydrogen peroxide for 2 h (pg. 3, “2.1. Samples”).
Regarding instant claim 5, Cruz teaches that hydrochloric acid used in the immersion has a concentration of 20% (v) (pg. 3, “2.1. Samples”).
Regarding instant claim 6, Cruz teaches that sulfuric acid used in the immersion has a concentration of 96% (v) (pg. 3, “2.1. Samples”).
Regarding instant claim 7, Cruz teaches that hydrogen peroxide used in the immersion has a concentration of 30% (v) (pg. 3, “2.1. Samples”).
Regarding instant claim 9, as noted above, Cruz teaches two consecutive washes with distilled water (pg. 3, “2.1. Samples”).
Regarding instant claim 10, as noted above, Cruz teaches two consecutive washes with distilled water followed by one with ethanol (pg. 3, “2.1. Samples”).
Regarding instant claim 12, the samples were cleaned with a sequence of 3 ultrasonic baths: two consecutive with distilled water, followed by one with ethanol (pg. 3, “2.1. Samples”).
Regarding instant claim 14, as noted in the 112(b) rejections above, the instant “use” claim does not recite any active steps, rendering the scope of the claim indefinite. However, it is interpreted that Cruz teaches the use of Piranha comprising sulfuric acid and a 50:50 ratio of hydrochloric acid and hydrogen peroxide for the passivation of titanium alloy dental meshes (see entire document, particularly abstract and pg. 3, “2.1. Samples”).
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.
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, 4-10, 12, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Cruz et al. (“Relevant Aspects of Piranha Passivation in Ti6Al4V Alloy Dental Meshes” Coatings 2022, 12, 154; included on IDS submitted 02/06/2024) hereafter “Cruz”.
Regarding instant claim 1, Cruz teaches the passivation of titanium alloy dental meshes (see entire document, particularly abstract). Titanium meshes are used as medical implants for bone regeneration (see pg. 2-3, “Introduction”, particularly paragraph 3). Cruz teaches Piranha passivation of titanium alloy meshes wherein the meshes were immersed in a mixture of sulfuric acid and a 50:50 ratio of hydrochloric acid and hydrogen peroxide (pg. 3, “2.1. Samples”). The samples were cleaned with a sequence of 3 ultrasonic baths: two consecutive with distilled water, followed by one with ethanol (pg. 3, “2.1. Samples”).
Regarding instant claim 4, Cruz teaches immersion of the meshes in a mixture of sulfuric acid and a 50:50 ratio of hydrochloric acid and hydrogen peroxide for 2 h (pg. 3, “2.1. Samples”).
Regarding instant claim 5, Cruz teaches that hydrochloric acid used in the immersion has a concentration of 20% (v) (pg. 3, “2.1. Samples”).
Regarding instant claim 6, Cruz teaches that sulfuric acid used in the immersion has a concentration of 96% (v) (pg. 3, “2.1. Samples”).
Regarding instant claim 7, Cruz teaches that hydrogen peroxide used in the immersion has a concentration of 30% (v) (pg. 3, “2.1. Samples”).
Regarding instant claim 8, Cruz teaches that there are many different mixture ratios of Piranha solutions that are commonly used which can favor cleanliness and increase oxide stabilization, and decompose organic contaminant; Cruz teaches Piranha solutions must be made with care as it is highly corrosive and a powerful oxidizer (pg. 3, “2.1. Samples”).
Regarding instant claim 9, as noted above, Cruz teaches two consecutive washes with distilled water (pg. 3, “2.1. Samples”).
Regarding instant claim 10, as noted above, Cruz teaches two consecutive washes with distilled water followed by one with ethanol (pg. 3, “2.1. Samples”).
Regarding instant claim 12, the samples were cleaned with a sequence of 3 ultrasonic baths: two consecutive with distilled water, followed by one with ethanol (pg. 3, “2.1. Samples”).
Regarding instant claim 14, as noted in the 112(b) rejections above, the instant “use” claim does not recite any active steps, rendering the scope of the claim indefinite. However, it is interpreted that Cruz teaches the use of Piranha (sulfuric acid and a 50:50 ratio of hydrochloric acid and hydrogen peroxide) for the passivation of titanium alloy dental meshes (see entire document, particularly abstract and pg. 3, “2.1. Samples”).
Cruz does not teach the ratios of hydrochloric acid and sulfuric acid to hydrogen peroxide of instant claim 8 with sufficient specificity to anticipate the instant claim. However, as noted above, Cruz teaches that many mixture ratios of Piranha solutions are known, and that different effects such as cleanliness and increased oxide stabilization can be achieved by adjusting the ratios; Cruz further teaches that Piranha solutions must be mixed with care as the mixtures are corrosive and powerful oxidizers. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to routinely optimize the ratios of hydrochloric acid and sulfuric acid to hydrogen peroxide, as suggested by Cruz, in order to reach a Piranha mixture that achieves a desired cleaning and oxide stabilization effect while minimizing the potentially dangerous oxidizing effects of such mixtures. Per MPEP 2144.05 II. A., “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here 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).”
Claims 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Cruz as applied to claims 1, 4-10, 12, and 14 above, and further in view of Doe et al. (“Titanium surface treatment by calcium modification with acid-etching promotes osteogenic activity and stability of dental implants” Materialia 2020, 12, 100801; included on IDS submitted 08/12/2025), hereafter “Doe”.
The teaching of Cruz are described above.
Cruz does not teach that the solution that the surgical implant is immersed in comprises divalent cations (instant claim 2) wherein said divalent cations are calcium (Ca2+) and/or magnesium (Mg2+) (instant claim 3).
Doe teaches that acid-etched titanium implants with applied calcium modification obtains remarkably high osteogenic activity and high stability in osseous tissue, and that calcium-modified acid-etched titanium might be particularly suitable as a biomaterial for dental implants (see entire document, particularly Abstract and Conclusions). Doe teaches immersing a titanium dental implant in an aqueous solution of calcium chloride (pg. 2, “2.1. Preparation of pure titanium implant” and “2.3. Calcium ion surface modification method”).
It would have been prima facie to one of ordinary skill in the art before the effective filing date of the instant invention to include the calcium ions taught by Doe in the immersion solution in the solution of Cruz. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success in order to incorporate a component known to modify the surface of acid-etched titanium dental implants which can combine the effects of both roughened titanium and calcium modification in order to achieve implants with high osteogenic activity and superior biocompatibility, as suggested by Doe (see particularly Abstract; pg. 2, column 1, paragraph 3; Conclusions). There is a reasonable expectation of success as Cruz teaches acid passivation of titanium-containing dental meshes and further teaches that surface properties can be optimized to improve functions such as bioactivity and osseointegration (see “Introduction”, particularly paragraph 5).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Cruz as applied to claims 1, 4-10, 12, and 14 above, and further in view of Zhang et al. (CN 102978677A, published March 20, 2013; included on IDS submitted 02/06/2024, translation included with IDS referred to below), hereafter “Zhang”.
The teaching of Cruz are described above. Further regarding instant claim 11, Cruz teaches that samples were cleaned with a sequence of 3 ultrasonic baths: two consecutive with distilled water, followed by one with ethanol, for 3 min each (pg. 3, “2.1. Samples”). The three minute washes of Cruz are interpreted as close to the claimed 1 min to 2 min range which, absent a showing of unexpected results or criticality of the claimed wash times, renders the claimed range prima facie obvious. Per MPEP 2144.05 I., “Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985)”.
Further, the prior art of Zhang teaches acid passivation of dental implants comprising titanium (pg. 1, paragraph 1; claims 1 and 5-6) which can prevent titanium or a titanium alloy from being corroded (pg. 2, “(1) chemical passivation”). Zhang exemplifies that, following acid passivation, the titanium is rinsed multiple times with water for 1-2 minutes each (Embodiments 1-5). This suggests to one of ordinary skill in the art that wash times of 1-2 minutes, consistent with the range of the instant claim, are suitable to wash acid-passivated titanium containing dental implants and achieve a material resistant to corrosion, and could routinely optimize the wash times accordingly. Per MPEP 2144.05 II. A., “[W]here 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).”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUDITH M KAMM whose telephone number is (703)756-4575. The examiner can normally be reached M-F 8:00 am-4:30 pm EST.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/J.M.K./Examiner, Art Unit 1611