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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 8/17/2026 has been entered.
Response to Arguments
Applicant’s arguments filed 8/17/2026 have been considered but are moot in view of the new grounds of rejection necessitated by the amendments.
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 21, 22, and 29-31 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. Claims 21, 22, and 29-31 are unclear because they recite “a calcium phosphate layer comprising calcium phosphate is deposited on the electrically conductive material of the base body” but claim 1 requires “the calcium hydroxide layer being deposited on the electrically conductive material of the base body” and claim 25 requires “depositing a calcium hydroxide layer comprising calcium hydroxide to the electrically conductive material of the base body”. The specification discloses two examples wherein in example 1 the implant is “without a calcium phosphate intermediate layer” (pg.12) and in example 2 (pg.13) the implant is “with a calcium phosphate intermediate layer”. It appears claims 21, 22, and 29-31 are directed to the embodiment comprising an intermediate calcium phosphate layer, but it is unclear how the calcium hydroxide layer can be “deposited on the electrically conductive material” when the intermediate calcium phosphate layer is deposited on the electrically conductive material. For examination, the limitation “deposited on” is interpreted as being either indirectly or directly on the electrically conductive material. Please clarify.
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.
Claims 16-20, 23, 25-28, and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Rubbert et al. US 2012/0064489 (hereafter referred to as Rubbert) in view of Yasaei et al. "Characteristics improvement of calcium hydroxide dental cement by hydroxyapatite nanoparticles. Part 1: Formulation and microstructure", 3 September 2013, Wiley Online Library, Pages 502-509 (hereafter referred to as Yasaei).
Regarding claim 16, Rubbert discloses an implant 200 or implant component (the root of the prosthetic tooth) (at least figs. 22, 53, and 54), comprising (a) a base body of an implant or an implant component, comprising an electrically conductive material at least on a surface (par.57 discloses at least the root portion is titanium and applicant discloses titanium is a preferred electrically conductive material on page 4, lines 22-23 of the instant application specification); and (b) a calcium hydroxide layer comprising calcium hydroxide, the calcium hydroxide layer being deposited on the electrically conductive material of the base body (par.205 discloses coating the portion to be implanted with calcium hydroxide cement). Rubbert discloses the invention substantially as claimed, but Rubbert does not disclose wherein the calcium hydroxide layer comprises calcium phosphate in addition to the calcium hydroxide, wherein a proportion of calcium phosphate in the calcium hydroxide layer is in the range of >2% by weight to <50% by weight, the weight percentage being based on the total weight of the calcium hydroxide layer, wherein the calcium phosphate is present in the form of particles in the calcium hydroxide layer.
Yasaei teaches a calcium hydroxide material, in the same field of endeavor wherein calcium phosphate nanoparticles are in a calcium hydroxide cement (fig.5a), wherein a proportion of calcium phosphate in the calcium hydroxide layer is in the range of >2% by weight to <50% by weight (see 3 wt% and 7wt% on pg.503 in the first paragraph under 2.2) for the purpose of increasing the compressive strength of calcium hydroxide cement without lessening antibacterial properties as well as improving the mineralization potential (pg.509, col.1, par.1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the calcium hydroxide cement layer of Rubbert to include 3 wt% of calcium phosphate nanoparticles as taught by Yasaei in order to increase the compressive strength of the calcium hydroxide cement without lessening antibacterial properties, as well as improve the mineralization potential.
Regarding claims 17 and 18, see Yasaei for hydroxyapatite (HA) on at least pg. 509, col.1, par.1.
Regarding claims 19 and 20, see Rubbert par. 57 for titanium which is a metal.
Regarding claim 23, Rubbert discloses a coating on the implanted portion of the implant with calcium hydroxide cement and this coating is considered a layer. It is generally desirable in the art to provide coatings/layers of uniform thickness in order to provide a uniform benefit in use and as such, it would have been obvious to apply the calcium hydroxide layer of Rubbert such that there is an equal layer thickness over the entire extent of the layer. Rubbert further discloses a thin coating/layer thickness of about 0.05 mm to 0.2 mm in par.200 and it would have been obvious to optimize the layer thickness to be in the range of from 1 to 50 microns since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art (In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955), MPEP 2144.05 II A).
Regarding claim 25, Rubbert discloses a method for manufacturing an implant 200 or an implant component (the root of the prosthetic tooth) (at least figs. 22, 53, and 54), comprising the steps of (a) providing a base body of an implant or an implant component, the base body comprising an electrically conductive material at least on a surface (par.57 discloses at least the root portion is titanium); and (b) depositing a calcium hydroxide layer comprising calcium hydroxide to the electrically conductive material of the base body (par.205 discloses coating the portion to be implanted with calcium hydroxide cement). Rubbert discloses the invention substantially as claimed, but Rubbert does not disclose wherein the calcium hydroxide layer is deposited such that it comprises calcium phosphate in addition to the calcium hydroxide, wherein a weight percentage of calcium phosphate is less than the weight percentage of calcium hydroxide, wherein a proportion of calcium phosphate in the calcium hydroxide layer is in the range of >2% by weight to <50% by weight, wherein the weight percentage is based on the total weight of the calcium hydroxide layer, wherein the calcium phosphate is present in the form of particles in the calcium hydroxide layer.
Yasaei teaches a calcium hydroxide material, in the same field of endeavor wherein calcium phosphate nanoparticles are in a calcium hydroxide cement (fig.5a), wherein a proportion of calcium phosphate in the calcium hydroxide layer is in the range of >2% by weight to <50% by weight (see 3 wt% and 7wt% on pg.503 in the first paragraph under 2.2), wherein a weight percentage of calcium phosphate is less than the weight percentage of calcium hydroxide (Table 1 on pg. 504 shows 50% calcium hydroxide therefore cement comprising 3 wt% or 7wt% calcium phosphate has less weight percentage of calcium phosphate than weight percentage of calcium hydroxide) for the purpose of increasing the compressive strength of calcium hydroxide cement without lessening antibacterial properties as well as improving the mineralization potential (pg.509, col.1, par.1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the calcium hydroxide cement layer of Rubbert to include 3 wt% of calcium phosphate nanoparticles as taught by Yasaei in order to increase the compressive strength of the calcium hydroxide cement without lessening antibacterial properties, as well as improve the mineralization potential.
Regarding claim 26, see Yasaei for hydroxyapatite (HA) on at least pg. 509, col.1, par.1.
Regarding claims 27 and 28, see Rubbert par. 57 for titanium which is a metal.
Regarding claim 32, Rubbert discloses coating the implanted portion of the implant with calcium hydroxide cement and this coating is considered a layer. It is generally desirable in the art to provide coatings/layers of uniform thickness in order to provide a uniform benefit in use and as such, it would have been obvious to apply the calcium hydroxide layer of Rubbert such that there is an equal layer thickness over the entire extent of the layer. Rubbert further discloses a thin coating/layer thickness of about 0.05 mm to 0.2 mm in par.200 and it would have been obvious to optimize the layer thickness to be in the range of from 1 to 50 microns since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art (In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955), MPEP 2144.05 II A).
Claims 21, 22, and 29-31 are rejected under 35 U.S.C. 103 as being unpatentable over Rubbert in view of Yasaei as applied to claims 16 and 25 above, and further in view of Shimamune et al. US 4,882,196 (hereafter referred to as Shimamune). Rubbert in view of Yasaei discloses the implant component according to claim 16 and the method according to claim 25 as discussed above. However, Rubbert in view of Yasaei does not disclose a calcium phosphate layer comprising calcium phosphate deposited on the electrically conductive material of the base body, wherein the calcium phosphate weight percentage is greater than a calcium hydroxide weight percentage in the calcium phosphate layer, wherein the calcium phosphate layer is deposited by means of electrochemical deposition and/or has a layer thickness in the range of 2 to 500 µm.
Shimamune teaches an implant and method of making an implant, in the same field of endeavor, wherein a calcium phosphate layer is deposited on a titanium implant surface by means of electrochemical deposition, wherein the calcium phosphate layer is free of calcium hydroxide (Shimamune does not disclose any calcium hydroxide), and wherein the calcium phosphate layer has a thickness of about 2 µm (col.6, lines 1-2) for the purpose of providing a base layer which has a high affinity for the substrate and sufficiently high strength (col.4, line 65-col.5, line 11).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the titanium base body material of Rubbert in view of Yasaei by depositing a calcium phosphate layer by at least electrochemical deposition having a thickness of about 2 µm as taught by Shimamune in order to provide an implant material that has a strong and biocompatible coating.
Conclusion
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/MEGAN Y WOLF/Primary Examiner, Art Unit 3774
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