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 .
Election/Restrictions
Applicant's election with traverse of Group I in the reply filed on 7/10/2026 is acknowledged. The traversal is on the ground(s) that the invention groups do make a contribution over the prior art. The examiner respectfully disagrees. It is maintained that the listed groups lack unity of invention because their technical feature is not a special technical feature as it does not make a contribution over the prior art, as indicated by the Homsy reference and the rejection cited below. Claims 7-11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Group II, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 7/10/2026. The requirement is still deemed proper and is therefore made FINAL.
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.
Claim(s) 1-6 and 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wagener et al. (EP 1790224 A1; hereinafter “Wagener”) in view of Pletcher (Pub. No.: US 2016/0158976 A1).
Wagener teaches the following regarding claim 1: an implant (pgs. 7-8 of the provided translation), with a base material (substrate) and a coating (pg. 3) located thereon, the coating comprising a biocide layer (biocide layer) and a barrier layer (transport control layer) covering the base material (pg. 3) and, compared to the uncoated base material, is adapted to reduce both access of oxygen to the base material (pg. 4) and exit of material from the base material (pgs. 4, 6-7, as the oxygen permeability and the rate of exit of material is reduced at the coating compared to an uncoated, open environment), wherein the coating only partially covers the base material (pgs. 6-8), at a surface section lying outside a sliding surface (an exterior surface of the implant) of the implant (pgs. 6-8).
Wagener teaches the limitations of the claimed invention, as described above. It further states that its layers can be applied to virtually any substrate base material (pg. 4). However, it does not specify that the base material is ultra-high molecular weight polyethylene. Pletcher teaches that it is well known in the art that a partially-coated implant has a substrate base material comprising ultra-high molecular weight polyethylene (paras. 0002, 0053-0057), for the purpose of optimizing the implant’s mechanical properties and biocompatibility. It would have been obvious to one having ordinary skill in the art to modify the device of Wagener to comprise ultra-high molecular weight polyethylene as its base material, as taught by Pletcher, in order to optimize the implant’s mechanical properties and biocompatibility. In addition, it has been held that a simple substitution of one known element for another to obtain predictable results, in the instant case, replacing one type of substrate material for another, is generally considered to be within the level of ordinary skill in the art.
Wagener teaches the following regarding claim 2: the implant according to claim 1, wherein the biocide layer comprises a biocidal active ingredient which is selected from the group consisting of silver, copper and zinc, ions thereof and metal complexes thereof, or a mixture or alloy comprising two or more of these elements (pgs. 4-6).
Wagener teaches the following regarding claim 3: the implant according to claim 2, wherein the barrier layer has a thickness and porosity adjusted to release the biocidal active ingredient from the biocide layer through the barrier layer in an antimicrobial, non-cytotoxic amount (pg. 3).
Wagener teaches the following regarding claim 4: the implant according to claim 1, wherein the biocidal active ingredient has an average grain size of 5 to 100 nm, an average thickness of the biocide layer is 5 to 100 nm, and an average thickness of the barrier layer is 5 to is 500 nm (pgs. 11-12).
Wagener teaches the following regarding claim 5: the implant according to claim 1, wherein the barrier layer has a base material which is selected from the group comprising an organic base material, a sol-gel, a lacquer and a siliconized base material (pg. 6).
Wagener teaches the following regarding claim 6: the implant according to claim 1, wherein the barrier layer has an inorganic base material which is selected from the group comprising SiO2, SiC, a metal oxide, and a non-biocidal metal (pg. 6).
Wagener teaches the following regarding claim 12: the implant according to claim 1, wherein the barrier layer has a base material which is selected from the group comprising a plasma polymer, a sol- gel, a lacquer and a siliconized base material (pg. 6).
Wagener teaches the following regarding claim 13: the implant according to claim 1, wherein the barrier layer has an inorganic base material which is selected from the group comprising SiO2, SiC, TiO2, A1203, and titanium and medical grade stainless steel (pg. 6).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ann Hu whose telephone number is (571) 272-6652. The examiner can normally be reached on Monday-Friday (9:00 am-5:30 pm EST).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Jerrah Edwards, at (408) 918-7557. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/ANN HU/Primary Examiner, Art Unit 3774
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