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 .
Response to Arguments
Applicant's arguments filed 1/29/2026 have been fully considered. Arguments regarding the objections to the drawings and specification are persuasive and the objections are withdrawn.
Applicant’s arguments regarding the rejection of claims 16-20, 23-28, and 32-34 under 35 U.S.C. 102(a)(1) as being anticipated by Moseke have been fully considered but they are not persuasive. Applicant argues Moseke does not disclose a base body of an implant or an implant component, but merely corundum-blasted titanium discs. Applicant argues the ordinary skilled person does not and would not understand each and every product which can be implanted as a base body of an implant or implant component and argues a base body has to have certain features to qualify as an implant or implant component, which a simple titanium disc does not have. These arguments are not persuasive because a base body of an implant or implant component is extremely broad. Applicant does not point out what “certain features” qualify as an implant or implant component. The only features required by the claim are related to materials. No implant or implant component structure or “features” are required by the claims and the examiner maintains that a coated titanium disc can be used as an implant or implant component. For example, there are bone plugs made of titanium that are used as implants, or the coated titanium disc of Moseke could be implanted as part of research trials. The argument that applicant’s opinion is supported by the conclusion of Moseke since Moseke concludes that calcium hydroxide coatings would be very promising coatings for titanium implants actually further supports the examiner’s position that the titanium and calcium hydroxide coatings of Moseke can be used as implants since Moseke says as much.
Applicant argues Moseke does not disclose that the calcium hydroxide layer comprises calcium phosphate. Applicant states that Moseke explicitly discloses that crystallographic analysis of the deposited coatings showed that mineralization of CaP was inhibited by the presence of citrate ions and that the coatings thus consisted of pure Ca(OH)2. The examiner does not see such language in the first paragraph of the results and discussion of the Moseke reference relied upon. It appears applicant may be referring to the one page reference cited by applicant rather than the six page reference provided by the examiner. In the reference relied upon, the first paragraph of the results and discussion section of Moseke discusses how varying parameters leads to better results regarding formation and homogeneity of the deposition of Ca(OH)2. This paragraph implies that some parameter sets lead to less than pure Ca(OH)2.
Applicant argues Moseke does not mention the concentration of citric acid in the electrolyte used. Again, it appears applicant may have been referencing the 1 page Moseke reference as opposed to the reference relied upon and provided by the examiner in the non-final rejection. Table 1 of Moseke clearly discloses a concentration of citric acid as shown below. Table 1 of Moseke also shows the exact same materials used in the instant application. Based on the parameters below, it appears that at least some calcium phosphate will form for some parameter sets. Since the claims only require >0% by weight, even a very small amount of calcium phosphate in the coating would anticipate the claim. Applicant could provide data showing that none of the parameter sets (1-9 in Table 1) of Moseke would result in any CaP in the calcium hydroxide layer.
PNG
media_image1.png
340
798
media_image1.png
Greyscale
Applicant argues Moseke assumes a transformation of the calcium hydroxide into pure calcium phosphate (HA) which is demonstrated in various physiological fluids after insertion of the calcium hydroxide layer in the fluids for a period of 17 days. Applicant argues in the most body-like fluid, FCS, HA only becomes visible in the XRD curve after 10 days which means the benefits of HA are formed only after a very long time, whereas it’s present from the outset in the layer deposited according to the invention. This is not persuasive because the claims do not specify any particular time at which the HA is present in a particular weight percent. Accordingly, even in the 10 day example discussed by applicant, as Ca(OH)2 transforms to HA, at some point the calcium hydroxide layer comprises calcium phosphate in a concentration of >0% wt to <40% wt of the total calcium hydroxide layer and meets the claims. Applicant did not address the examiner’s discussion of claims 17 and 18 which pointed out that Moseke fig.3b at day 1 shows some HA in the coating (see annotated fig.3b below). The examiner explained that this intermediate product anticipates the claim. Even a pure Ca(OH)2 coating will transform to HA in the body, and at some point during the transformation inherently comprises a calcium hydroxide layer comprising calcium phosphate in a range from >0% by weight to <40% by weight.
PNG
media_image2.png
658
517
media_image2.png
Greyscale
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 16-20, 23-28, and 32-34 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Moseke et al. "Electrochemically Deposited Ca(OH)2 Coatings as a Bactericidal and Osteointegrative Modification of Ti Implants" Adv. Eng. Mat. 11:B1-B6, 2009 (hereafter referred to as Moseke).
Regarding claim 16, Moseke discloses an implant or implant component (page B1, col. 2, par.3), comprising (a) a base body of an implant or an implant component, comprising an electrically conductive material at least on a surface (page B1, col.2, par. 4 discloses a titanium disk which is considered a base body of an implant or implantable component since it can be implanted; the claim does not define any particular implant or implant component shape, features or structure); and (b) a calcium hydroxide layer comprising calcium hydroxide, the calcium hydroxide layer being deposited on the electrically conductive material of the base body; wherein the calcium hydroxide layer 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, the weight percentage being based on the total weight of the calcium hydroxide layer (page B4, fig.3 shows Ca(OH)2 and what appears to be no or minimal calcium phosphate before immersion in SBF, DMEM, and FCS; fig.3b shows a small amount of HA at day 1 and an intermediate product occurring during the transformation of the Ca(OH)2 to HA inherently comprises the claimed range of >0% to <40%, for example when Ca(OH)2 first starts to transform to HA). Additionally, the examiner notes that Moseke discloses the same materials and methods (see Moseke Table 1) as those disclosed in the instant application. As such, several of the parameter sets in Table 1 appear to yield a calcium hydroxide layer as claimed with at least some small amount of calcium phosphate based on the concentrations used. Once a reference teaching a product appearing to be substantially identical is made the basis of a rejection, and the examiner presents evidence of reasoning tending to show inherency, the burden shifts to the applicant to show an unobvious difference (MPEP 2112 V).
Regarding claims 17 and 18, see fig.3b at day 1 which shows some hydroxyapatite (HA) in the coating. This intermediate product anticipates the claim.
Regarding claims 19 and 20, see page B1, col.2, par.4 for commercially pure titanium.
Regarding claims 23 and 32, see page B1, col.2, heading “Electrochemical Deposition” and page B3, col.2, par.1 for about 20 µm.
Regarding claims 24 and 33, see fig.3b at day 1 for HA between >0 % and <40 % by weight.
Regarding claim 25, see the rejection of claim 16 above as well as the method disclosed on page B1, col.2, par.4 and in Table 1.
Regarding claim 26, see fig.3b at day 1 which shows some hydroxyapatite (HA) in the coating.
Regarding claims 27 and 28, see page B1, col.2, par.4 for commercially pure titanium.
Regarding claim 34, since the materials of Moseke are the same as the instant application, it appears the calcium phosphate is inherently in the form of particles in the calcium hydroxide layer. It is unclear what other form the calcium phosphate could be in.
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 21, 22, and 29-31 are rejected under 35 U.S.C. 103 as being unpatentable over Moseke 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). Moseke discloses the implant component according to claim 16 and the method according to claim 25 as discussed above. However, Moseke 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 Moseke 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
THIS ACTION IS MADE FINAL. 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 MEGAN Y WOLF whose telephone number is (571)270-3071. The examiner can normally be reached Mon-Fri 8am-2pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at (571)272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MEGAN Y WOLF/Primary Examiner, Art Unit 3774
Prosecution Insights