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
Claims 15,17,18,20,23,26,29,32,37,38 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/26/25. The examiner would like to note claim 39 is to another specie or invention as it recites a “non-perforated” implant requiring specific pore sizes, not required by the implant of claim 1. Therefore, the implant of claim 1 is defining an implant with much larger pores not of the claim recited dimension in claim 39 because as best understood the preamble states it is “non-perforated” and claim 1 is not excluding a perforated implant which one of ordinary skill may consider the implant to be perforated since the claim recites there are pores. Thus claim 39 is withdrawn.
Claim Objections
Claims 35, 36 are objected to because of the following informalities: claims 35, 36, are improper use claims. Claim 35 recites in the preamble, a “use” but fails to define any particular steps in how the bone implant is used. The claim recites the “implant” is in a material, but adds no structural details and the material is already recited in claim 1 from which it depends. Claim 36 recites intended uses, but fail to detail how the implant is applied/used in the recipient/patient or any particular structure to define the type of implant. Appropriate correction is required.
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 35, 36 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 35 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. The omitted steps are: the use of a “bone implant” in a material makes no sense as the implant inherently includes a material and thus it is not understood how it is used in a material. The claim fails to define any particular step in where it is placed to provide a “use” to indicate what it is doing or functioning as. In claim 36 it is not understood the recitation of “material is a……or a cranium” because is this meaning that of a natural skull or head? Or is the recitation meant that the material could be shaped as cranium implant?
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.
Claim(s) 1,2,13 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Liu (CN 85101505). Please note the preamble carries no weight when the body of the claim recites no structure to limit the preamble to any intended use. Liu disclose a device comprising:(1) a substrate; (abstract) and (2) a porous membrane on the substrate, page 4 of translation wherein the substrate is a tantalum substrate and the porous membrane is a porous lithium tantalate membrane, wherein the substrate is a niobium substrate and the porous membrane is a porous lithium niobate membrane, or wherein the substrate is a tantalum-niobium alloy substrate and the porous membrane is a porous lithium tantalate-lithium niobate mixture membrane. Regarding claim 2, Liu discloses (pages 2,4 of translation) the substrate can be one of either tantalum, niobium or a tantalum-niobium alloy and a porous lithium tantalate membrane on the tantalum substrate, wherein the lithium tantalate membrane contains a tantalum oxide, a porous lithium niobate membrane on the niobium substrate, wherein the lithium niobate membrane contains a niobium oxide, or a porous lithium tantalate-lithium niobate mixture membrane on the tantalum- niobium alloy substrate, wherein the mixture membrane contains a tantalum oxide and a niobium oxide. With respect to claim 13, please note the recitation of the claimed substrates being either “porous or dense” is relatively broad and unlimited as these are essentially opposite conditions. For example, a porous substrate could be considered non-solid, whereas a dense substrate could be a solid material with no pores. Liu discusses density of the substrates (page 6 of translation) and thus it can be construed the substrates are not porous but dense.
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) 1-4,10,13,35,36 are rejected under 35 U.S.C. 103 as being unpatentable over Fernandes et al. (EP 3195825) in view of Astra Tech (CN 101686861). Fernandes et al. disclose (paragraph 30) a bone implant, specifically a dental implant that comprises a substrate that can be tantalum or its alloys, paragraph 47. Fernandes et al. also disclose (paragraphs 32,35,37,90) there can be a film or coating to define a porous membrane on the substrate. Fernandes et al. disclose (paragraphs 26,29,31) the film or coating that forms a membrane on the substrate can include tantalum, but did not state the coating is a lithium tantalate membrane. Astra Tech teaches (paragraphs 25-28) that bone implants can be provided with a lithium oxide coating or film that improves bone integration and mineralization about the implant to increase its stability. It would have been obvious to one of ordinary skill in the art to utilize lithium in a coating as taught by Astra Tech and incorporate with the porous tantalum coating of Fernandes et al. such that it improves the properties of the porous film and increases stability of the implant. With respect to claim 2, Fernandes discloses the substrate can be tantalum (paragraph 51) and the lithium tantalate membrane per the modification with Astra Tech produces the porous lithium tantalate with a tantalum oxide, see paragraph 26 of Fernandes. Regarding claim 3, Fernandes discloses (paragraph 40) the pores in the coating or membrane have a diameter within the claimed range of 0.1-1 µm. Regarding claim 4, Fernandes discloses (paragraph 39) the porous membrane can have a thickness within the claimed range of 1-20 µm. Regarding claim 13, Fernandes discloses (paragraph 46) the substrate can be either porous or dense. With respect to claims 10, 35 Fernandes discloses (paragraph 17) the implant is used in bone and has material with improved growth stabilization. Regarding claims 10,36 Fernandes discloses (paragraph 30) the implant can be a dental type.
Claim(s) 5 is rejected under 35 U.S.C. 103 as being unpatentable over Fernandes et al. (EP 3195825) in view of Astra Tech (CN 101686861) as applied to claim 1 above, and further in view of Choe Han et al. (KR 102107725). Fernandes et al. in view of Astra Tech is explained supra. Please note in the realm of materials, properties are inherent to the material when they are the same. Since the modifications of Astra Tech with Fernandes et al. is to result in the claimed lithium tantalate membrane, it inherently must have the same elasticity modulus of at least 150 GPa or an elasticity modulus of 30-140 GPa. However in the alternative, Fernandes et al. as modified by Astra Tech did not disclose the bone implant has an elasticity modulus of at least 150 GPa or an elasticity modulus of 30-140 GPa. Choe Han et al. teach (page 2 of translation) that a bone or dental implant has an elasticity modulus of 30-140 GPa. It would have been obvious to one of ordinary skill in the art to provide the bone implant with an elasticity modulus that falls within the claimed range of 30-140 GPa as taught by Choe Han et al. for the implant of Fernandes et al. as modified with Astra Tech such that it reduces the stress shielding effect with the bone and improves corrosion resistance and biocompatibility, see page 4 of translation of Choe Han.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Liu (4810584) teaches a lithium tantalum oxide coated tantalum substrate.
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/BRIAN E PELLEGRINO/Primary Examiner, Art Unit 3799