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 .
Withdrawn Objections/Rejections
The rejections of claims 2-3 and 14 are withdrawn in view of the cancellation of the claims.
The rejections of claims 5-7 and 11 under 35 U.S.C. § 112(b) are withdrawn in view of the claim amendments.
The rejections of claims 1, 4-7, 9-10, and 12 under 35 U.S.C. § 102 are withdrawn in view
of the claim amendments.
The previous rejections of claims 1 and 4-12 under 35 U.S.C. § 103 are withdrawn in view
of the claim amendments.
Election/Restrictions
Newly added claims 15 and 16 are directed to an invention of a surgical implant; this invention was non-elected without traverse in the response filed 01/29/2026. Accordingly, claims 15 and 16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/29/2026.
Claim Status
Applicants' amendments and arguments filed on 05/19/2026 have been fully considered.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.
The following rejections and/or objections are either reiterated or newly applied. They constitute the
complete set presently being applied to the instant application.
Claims 2-3 and 14 are cancelled.
Claims 15-16 are newly added.
Claims 13 and 15-16 are withdrawn.
Claims 1 and 4-12 are under current examination.
New Rejections Necessitated by Claim Amendments
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, and 12 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” 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”.
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”). 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).”
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”).
Cruz does not teach that the solution that the surgical implant is immersed in comprises divalent cations wherein said divalent cations are calcium (Ca2+) and/or magnesium (Mg2+) (instant claim 1).
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 method 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 in view of Doe as applied to claims 1, 4-10, and 12 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).”
Response to Arguments
Applicant’s arguments filed 05/19/2026 have been fully considered.
Regarding the claim rejections under 35 USC 103, Applicant argues that the cited references do not disclose or suggest the claimed surface morphology and its functional properties. Applicant argues that the method for passivating titanium alloy surfaces taught by Cruz results in a nanotextured surface; however, the claimed invention generates a specific nanostructured morphology, specifically a controlled nanostructure with defined nanoporosity, that is dependent on the composition of the treatment solution and process conditions. Applicant argues that the surface generated by the claimed method exhibits a significantly improved functional property of a marked reduction in bacterial adhesion which is neither disclosed nor suggested in Cruz or conventional acid-treated titanium surfaces (citing to Figures 3 and 4 of the instant invention). Applicant further argues that a person of ordinary skill in the art would not have been motivated to modify the process disclosed in Cruz in such a way as to obtain the specific surface morphology and associated functional properties of the present invention. Applicant argues that Cruz does not recognize the relationship between specific nanoscale morphology and antibacterial properties, nor provide guidance that would lead a POSITA to adjust the process parameters toward achieving the results demonstrated in the present invention.
These arguments are unpersuasive. The Examiner first notes that, contrary to Applicant's assertions, the claims do not recite any particular surface morphology nor functional properties. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Further, per MPEP 2144 IV., “The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006)”. The fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Applicant appears to be arguing that the method of the present invention has achieved unexpected results over the teachings of the prior art. However, per MPEP 716.02(e), “An affidavit or declaration under 37 CFR 1.132 must compare the claimed subject matter with the closest prior art to be effective to rebut a prima facie case of obviousness. In re Burckel, 592 F.2d 1175, 201 USPQ 67 (CCPA 1979).” Here, the evidence of record demonstrates that a composition of the present invention (specified to be HCl at 20% v/v, concentrated 96% v/v sulfuric acid and hydrogen peroxide at a concentration of 30% v/v, where a ratio of HCl and sulfuric acid to hydrogen peroxide is 50% each by volume) reduces bacterial adhesion when compared to a control (untreated) and HCl at a concentration of 1 M (see Examples 1 and 2 at pg. 6 of the specification). However, as set forth above, the prior art of Cruz similarly teaches the passivation of titanium alloy dental meshes wherein the meshes were immersed in a mixture of 96% (v) sulfuric acid and a 50:50 ratio of 20% (v) hydrochloric acid and 30% (v) hydrogen peroxide; 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”). The Examiner finds no comparison to the method of Cruz on the record. Thus, the Examiner cannot conclude that the method of the instant invention has achieved results that are unexpected over the teachings of the prior art.
Further, as set forth above, the prior art of Doe suggests that the calcium ion modification of acid-etched titanium implants results in remarkably high osteogenic activity and high stability in osseous tissues, providing motivation to the skilled artisan to modify the method of Cruz to include calcium ions in the immersion solution. This is consistent with the results described in the instant specification, which notes that divalent cations such as calcium and/or magnesium impregnate the passivation layer, and their release on physiological contact increases the speed of osteointegration (pg. 7, lines 6-11). Per MPEP 716.02 (c), “"Expected beneficial results are evidence of obviousness of a claimed invention, just as unexpected results are evidence of unobviousness thereof." In re Gershon, 372 F.2d 535, 538, 152 USPQ 602, 604 (CCPA 1967)”.
In view of the forgoing, and as further detailed in the above rejections, the Examiner maintains that the instant invention is rendered obvious by the teachings of the prior art.
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 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
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