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 .
Claim Rejections - 35 USC § 112
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 28, 29, 33, 35, and 37 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 28 recites the limitation "the isoelectric point" in line 2. Claim 29 recites “the total of all alkaline” in line 3. Claim 35 recites “the free surface energy” in line 2. Claim 37 recites “the density” in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 33 recites “an implantable or implant component”, however this limitation has already been established in claim 24 from which it depends. It is unclear if this is meant to refer to the same component or a different component.
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 24-38, 40 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Denzer (US 2009/0132048).
Denver shows a method of forming a protective layer on a surface of an implantable or implant component (abstract), the method comprising a) applying a solution on the surface of the component ([0028] describes the application), the solution having a pH at 25°C of 6.8 or less ([0014] discusses many possible combinations of cations and anions including sodium chloride and sodium nitrate which have pHs of approximately 6.24 and 6 in the disclosed concentration of 0.1M of [0028], respectively); and b) drying the applied solution to form a protective layer on the surface of the component for dental applications ([0028]-[0029] describes the drying step). With respect to claim 25, wherein the solution comprises monovalent inorganic cations other than H+ and H30+ ([0014]) and comprises monovalent, bivalent or trivalent inorganic anions (anions listed in [0014]). With respect to claim 26, wherein the monovalent inorganic cations comprise Na+, K+, or NH4+ ([0014] discloses Na+ and K+ for instance). With respect to claim 27, wherein the solution comprises inorganic bivalent cations ([0014] “bivalent cations”). With respect to claim 28, wherein the pH of the solution at 25°C is below the isoelectric point of the surface on which the protective layer is to be formed, and/or wherein the pH of the solution is 6.5 or less (pH is 6.5 or less as described in regards to claim 24). With respect to claim 29, wherein the solution comprises sodium cations (Na+), and the sodium cations form 30 - 100 mol% of the total of all alkaline and earth alkaline metal cations in the solution ([0013]-[0014] describe the use of a single salt so that the mol% of cations would be 100%, or less in combinations of salts), and wherein the solution comprises phosphate ([0014]), hydrogen phosphate and/or dihydrogen phosphate anions, and the phosphate, hydrogen phosphate and/or dihydrogen phosphate anions form 30 mol% or more of the total of all inorganic anions ([0013]-[0014] describe the use of a single salt so that the mol% of anions would be 100%, or less in combinations of salts). With respect to claim 30, wherein the solution comprises magnesium ions ([0014] discloses inclusion of magnesium [Mg]). With respect to claim 31, wherein the solution does not contain calcium ions ([0014] lists many salt compositions that do not contain calcium ions). With respect to claim 32, wherein the solution has a total concentration of inorganic salts of 1 to 200 mM ([0028] for instance discusses use of 0.01M to 1M, which is equivalent to 10 mM to 1000M; also discusses use of 0.1M which is equivalent to 100mM). With respect to claim 33, wherein the protective layer protects an implantable or implant component during storage against contamination ([0009]). With respect to claim 34, wherein the protective layer preserves the hydrophilicity of the implantable or implant component during storage ([0016]), in that the implantable or implant component exhibits a water contact angle of 0 - 30 both prior to the applying the solution and after rinsing the component with water at 25°C for 2 minutes, followed by the drying ([0003] discusses the range of contact angle for hydrophilic materials such as titanium, and since [0011] discusses no residue left and that the layer prevents compounds in the air from altering the hydrophilicity of the underlying material). With respect to claim 35, further comprising increasing the free surface energy of the implantable or implant component prior to or simultaneous with the applying the solution (hydrophilic surfaces are categorized by high surface energy, so the cleaning of [0027] prior to coating will remove the organic/carbon deposits and increase the surface energy/hydrophilicity). With respect to claim 36, wherein the protective layer preserves an amount of available functional groups of the surface of the implantable or implant component during storage ([0016] discusses how the protective layer protects the ions of the surface). With respect to claim 37, wherein the protective layer is configured to reduce carbon deposition and preserve hydrophilicity and/or the density of free/unbound hydroxyl groups on the surface of the implantable or implant component during dry storage as compared to storage without said protective layer ([0016] discusses this protection from organic/carbon compounds). With respect to claim 38, wherein the implantable or implant component is a dental implant or an abutment (abstract). With respect to claim 40, wherein the implantable or implant component is made from metal or metal alloy ([0001]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW NELSON whose telephone number is (571)270-5898. The examiner can normally be reached on Monday-Friday 7:30am-5:00pm EDT.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Eric Rosen, at (571) 270-7855. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW M NELSON/Primary Examiner, Art Unit 3772