DETAILED ACTION
This is in response to communication received on 10/13/25.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The text of those sections of AIA 35 U.S.C. code not present in this action can be found in previous office actions dated 7/18/24, 11/21/24, 3/14/25, and 7/15/25.
Claim Rejections - 35 USC § 103
The claim rejection(s) under AIA 35 U.S.C. 103 as being obvious over Layrolle et al. US Patent Number 6,207,218 hereinafter LAYROLLE in view of Asgari US PGPub 2008/0177378 hereinafter ASGARI on claim 1, 4-6, and 11 are withdrawn because the independent claim has been amended.
The claim rejection(s) under AIA 35 U.S.C. 103 as being obvious over Layrolle et al. US Patent Number 6,207,218 hereinafter LAYROLLE, Asgari US PGPub 2008/0177378 hereinafter ASGARI and Leitao et al. US Patent Number 6,136,369 hereinafter LEITAO on claim 3 is withdrawn because the independent claim has been amended.
The claim rejection(s) under AIA 35 U.S.C. 103 as being obvious over Layrolle et al. US Patent Number 6,207,218 hereinafter LAYROLLE, Asgari US PGPub 2008/0177378 hereinafter ASGARI and Harding et al. US PGPub 2017/0326272 hereinafter HARDING on claim 3 is withdrawn because the independent claim has been amended.
Claim(s) 1, 2, 4-6, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Layrolle et al. US Patent Number 6,207,218 hereinafter LAYROLLE in view of Forsgren et al. US PGPub 2011/0184529 hereinafter FORSGREN and Development of biodegradable ZN-1x binary alloys with nutrient alloying elements Mg, Ca and Sr by Xie et al hereinafter XIE.
As for claim 1, LAYROLLE teaches "The present invention relates to a method for coating a medical implant, wherein the implant is submersed in an aqueous solution of magnesium, calcium and phosphate ions through which a gaseous weak acid is passed, the solution is degassed, and the coating is allowed to precipitate onto the implant" (abstract, lines 1-6), and "In a preferred embodiment, the layers will be composed of hydroxyl carbonate apatite with a poor crystallinity or amorphous calcium phosphates containing magnesium and carbonate ions" (column 9, lines 19-22) wherein the coating has both magnesium and phosphorous, i.e. A method for preparing a biocompatible Mg-P coating on the surface of a ... biomedical material.
LAYROLLE teaches "The implants are ultrasonically cleaned for 10 minutes in acetone, ethanol (70%) and finally pure water" (column 11, lines 39-41 ), and "Metals, such as stainless steel, titanium, nickel, cobalt, chrome, niobium, molybdenum, zirconium, tantalum, and combinations thereof, can be coated with the carbonated calcium phosphate layers for orthopaedic and dental applications" (column 4, lines 60- 64) i.e. S1. Performing a pretreatment on the surface of the ... biomedical material to obtain a pretreated medical ... alloy, wherein, the pretreatment comprises ... an ultrasonic cleaning.
LAYROLLE teaches "The present invention relates to a method for coating a medical implant, wherein the implant is submersed in an aqueous solution of magnesium, calcium and phosphate ions through which a gaseous weak acid is passed, the solution is degassed, and the coating is allowed to precipitate onto the implant" (abstract, lines 1-6), "The calcifying solutions are composed of calcium, phosphate, magnesium, carbonate and additionally sodium chloride salts dissolved into water by bubbling carbon dioxide gas" (column 3, lines 62-65), and "The temperature is maintained at about 5--80° C., preferably in the range of about 5-50° C" (column 7, lines 40-41 ), i.e. S2. soaking the pretreated ... medical ... alloy obtained in step S1 in a slightly-acidic magnesium salt- and phosphate-containing solution at a constant temperature, and conducting chemical liquid deposition (CLD)… to obtain the biocompatible Mg-P coating.
LAYROLLE is silent on zinc. Its teachings are generally directed to metal.
XIE teaches “The results demonstrated that the Zn-1x (Mg, Ca and Sr) alloys showed great potential for use in a new generation of biodegradable implants, opening a new avenue in the area of biodegradable metals” (abstract, lines 10-14).
XIE further demonstrates “that the Zn-1X alloys have greatly enhanced mechanical properties, corrosion behavior and biocompatibility” (Discussion, lines 15-17).
It would have been obvious to one of ordinary skill in the art before the effective filing date to include having a zinc-based biomedical material… wherein the zinc-based biomedical material is one selected from the group consisting of… Zn-Sr binary alloy in the process of LAYROLLE because XIE teaches that such an alloy has improved mechanical, corrosion behavior and biocompatibility.
LAYROLLE further teaches stirring during its soaking so it does not teach by static soaking of the pretreated medical zinc alloy in the solution.
FORSGREN teaches “The invention relates to a substrate comprising a bioactive element and a method to obtain the substrate with the bioactive element. The plate comprising the bioactive element relies upon formation of a carbonate layer containing biologically relevant and active ions on a surface of the substrate” (abstract, lines 1-5) and “One embodiment of the present invention discloses a method of producing a biomedical implant” (paragraph 20, lines 1-2)
FORSGREN teaches “The present invention is based on surface mineralization of bioactive substrates where a carbonate layer is deposited on the surface of implants via soaking in specific salt solutions” (paragraph 8, lines 1-4) and “Subsequently, the sample is thoroughly rinsed with water and cleaned before immersed in the salt solution for 1-14 days at >0-95° C., preferably about 7 days at 60° C” (paragraph 49, lines 1-3), i.e. by static soaking… in the solution.
It would have been obvious to one of ordinary skill in the art before the effective filing date to include by static soaking of the pretreated medical zinc alloy in the solution in the process of LAYROLLE because FORSGREN teaches such a process can produce the carbonate coating containing the desired salts for implants.
LAYROLLE is further silent on soaking for between 2.5 hours to 6 hours.
However, LAYROLLE does teach "In the open bioreactor described herein, the complete exchange of dissolved CO2 gas with atmosphere takes approximately 8 to 48 hours ... The natural release of CO2 gas causes the pH of the remaining solution to increase (FIG. 2). In others words, saturation in the calcifying solution can increase until the precipitation of the bioactive layers on the surface of implantable materials occurs. Optionally, air can be bubbled through the solution to degas or aerate the solution and accelerate the escape, release or exchange of the gaseous weak acid" (column 7, lines 45-55), wherein the time it takes to perform the reaction can be shorten based on the bubbling of the air.
It would have been obvious to one of ordinary skill in the art before the effective filing date to design the time of the reaction such that the desired saturation is achieved. Discovery of optimum value of result effective variable in known process is ordinarily within the skill of the art. In re Boesch, CCPA 1980, 617 F.2d 272, 205 USPQ215.
As for claim 2, LAYROLLE teaches "wherein the coating comprises magnesium ions, calcium ions and phosphate ions and one or more ions selected from the group consisting of hydroxide, carbonate, chloride, sodium and potassium" (claim 21 ), i.e. wherein, in step S2 ... a phosphate of the slightly-acidic magnesium salt- and phosphate-containing solution is at least one selected from the group consisting of sodium phosphate.
LAYROLLE is silent on a magnesium salt of the slightly-acidic magnesium salt and phosphate-containing solution is at least one selected from the group consisting of magnesium sulfate.
FORSGREN teaches “For a person skilled in the art, it is obvious that it is possible to exchange the acetate to other salts or for solutions containing Ca, Mg, or Zn ions with their respective salts. Carbon in any form that can form carbonates needs to be present in the solution and can either be added to the solution as a soluble salt or from a gas source” (paragraph 49, lines 13-18).
It would have been obvious to one of ordinary skill in the art before the effective filing date to include magnesium salt of the slightly-acidic magnesium salt and phosphate-containing solution is at least one selected from the group consisting of magnesium sulfate in the process of LAYROLLE because FORSGREN teaches that such substitutions were well within the skill of the ordinary artisan to get the desired coating on the implant.
As for claim 4, LAYROLLE teaches "The concentrations of the ions in the calcifying solution are chosen such, that in the absence of the gaseous weak acid, the solution is super-saturated or oversaturated" (column 7, lines 26-28).
LAYROLLE further teaches "An increase of pH in the solution can induce the following stages: under-saturation, super-saturation or the formation of a meta-stable state, nucleation and crystal growth. Calcium phosphate nuclei can form onto a substrate-heterogeneous nucleation- when a solution has reached the super-saturation limit or the meta-stable state. At the super-saturation state, crystals can subsequently grow from metastable fluids. At higher saturation, homogeneous nucleation or precipitation in the solution is the predominant process. This invention makes use of pH changes to control the above stages and to induce the deposition of carbonated calcium phosphate layers on the surface of medical implants" (column 5, lines 44-55).
It would have been obvious to one of ordinary skill in the art before the effective filing date to design the concentration of the ions such that the desired super-saturation at the desired pH and thereby coating result is achieved. Discovery of optimum value of result effective variable in known process is ordinarily within the skill of the art. In re Boesch, CCPA 1980, 617 F.2d 272, 205 USPQ215.
As for claim 5, LAYROLLE teaches ""The temperature is maintained at about 5-80° C., preferably in the range of about 5-50° C" (column 7, lines 40-41 ), i.e. wherein, in step S2, the soaking is conducted at a range that overlaps with 10°c to B0°C. 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, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d, 1362, 1365-66 (Fed. Cir.1997). See MPEP 2144.05.
LAYROLLE teaches "During the natural release of CO2 gas out of the calcifying solution, the pH will increase to about 6-10, more preferably about 7.5 to 8 .5 after soaking for 24 hours" (column 7, lines 63-66), i.e. for ... 24 hours and the slightly-acidic magnesium salt- and phosphate-containing solution has a pH that overlaps with a range of 4hours to 5hours. 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, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d, 1362, 1365- 66 (Fed. Cir. 1997). See MPEP 2144.05.
As for claim 6, LAYROLLE teaches "The implants are ultrasonically cleaned for 10 minutes in acetone, ethanol (70%) and finally pure water" (column 11, lines 39-41), i.e. wherein the ultrasonic cleaning in step S1 comprises the ultrasonic cleaning successively with absolute ethanol, acetone, and water.
LAYROLLE is silent on ending with an acetone cleaning.
However, it is a prima facie case of obviousness to substitute one known element for another to obtain predictable results. In this case, both water and absolute ethanol are known elements for ultrasonic cleaning. It would be well within the skill of the ordinary artisan before the effective filing date to substitute the water of LAYROLLE with the acetone such that it includes wherein the ultrasonic cleaning in step S 1 comprises the ultrasonic cleaning successively with absolute ethanol, acetone, and absolute ethanol. In addition, it is the position of the examiner that the disclosure provides no evidence of criticality with regard to the chemical composition of the cleaning material. It is the position of the examiner that the criticality on the cleaning material does not provide patentable distinction as the limitation appears to incidental absent evidence, particularly considering the cleaning material does not form a part of the coating process, merely preparing the surface prior to the coating process.
As for claim 11, LAYROLLE teaches "The concentrations of the ions in the calcifying solution are chosen such, that in the absence of the gaseous weak acid, the solution is super-saturated or oversaturated" (column 7, lines 26-28).
LAYROLLE further teaches "An increase of pH in the solution can induce the following stages: under-saturation, super-saturation or the formation of a meta-stable state, nucleation and crystal growth. Calcium phosphate nuclei can form onto a substrate-heterogeneous nucleation- when a solution has reached the super-saturation limit or the meta-stable state. At the super-saturation state, crystals can subsequently grow from metastable fluids. At higher saturation, homogeneous nucleation or precipitation in the solution is the predominant process. This invention makes use of pH changes to control the above stages and to induce the deposition of carbonated calcium phosphate layers on the surface of medical implants" (column 5, lines 44-55).
It would have been obvious to one of ordinary skill in the art before the effective filing date to design the concentration of the ions such that the desired super-saturation at the desired pH and thereby coating result is achieved. Discovery of optimum value of result effective variable in known process is ordinarily within the skill of the art. In re Boesch, CCPA 1980, 617 F.2d 272, 205 USPQ215.
Claim(s) 3 is rejected under 35 U.S.C. 103 as being unpatentable over Forsgren et al. US PGPub 2011/0184529 hereinafter FORSGREN and Development of biodegradable ZN-1x binary alloys with nutrient alloying elements Mg, Ca and Sr by Xie et al hereinafter XIE further in view of Harding et al. US PGPub 2017/0326272 hereinafter HARDING.
As for claim 3, LAYROLLE is silent on the solubilizing salt comprises ethylene diamine tetreaacetic acid (EDTA).
However, LAYROLLE does teach "An increase of pH in the solution can induce the following stages: under-saturation, super-saturation or the formation of a metastable state, nucleation and crystal growth. Calcium phosphate nuclei can form onto a substrate-heterogeneous nucleation- when a solution has reached the super-saturation limit or the meta-stable state. At the super-saturation state, crystals can subsequently grow from metastable fluids. At higher saturation, homogeneous nucleation or precipitation in the solution is the predominant process. This invention makes use of pH changes to control the above stages and to induce the deposition of carbonated calcium phosphate layers on the surface of medical implants" (column 5, lines 44-55).
LAYROLLE teaches "The concentrations of the ions in the calcifying solution are chosen such, that in the absence of the gaseous weak acid, the solution is supersaturated or oversaturated" (column 7, lines 26-28).
HARDING teaches "The present invention relates to a method for in situ biomimetic mineralization of polymeric hydrogels, where the incorporated CaP phase can be selectively tuned in chemical composition and morphology to mimic bone and dental mineral" ( abstract, lines 1 -5).
HARDING further teaches "To prevent precipitation of CaP in solution as the pH is shifted towards alkaline conditions a back titration approach was utilized. In brief, 1 m I of analyte was added to 10 ml of standardized 5 mM EDTA solution" (paragraph 107, lines 1-6), wherein the addition of EDTA increases the solubility of CaP during processing.
It would have been obvious to one of ordinary skill in the art before the effective filing date to include the solubilizing salt comprises ethylene diamine tetreaacetic acid (EDTA) in the process of LAYROLLE because HARDING teaches the addition of that material improves solubility of the calcium phosphate in solution.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-6, 8-11 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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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/KRISTEN A DAGENAIS/Examiner, Art Unit 1717
/Dah-Wei D. Yuan/Supervisory Patent Examiner, Art Unit 1717
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