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 of invention 1 in the reply filed on 11/24/2025is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim 11-19 withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Information Disclosure Statement
The information disclosure statement filed 01/20/2023 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because a translated copy of the following have not been provided: the written opinion and the international search report of PCT/CN2021/101453. It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
Drawings
The drawings are objected to because figures 10-11 don’t comply with 37 CFR 1.84.
Drawings must be black and white; grayscale, color, or black and white photographs are not ordinarily. Permitted, solid black lines must be used for drawings.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: S300 in [0089] and S400 [0079]. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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) 1-3. 5, and 7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sequeda (US 20160122865 A1).
Regarding claim 1, Sequeda teaches an implantable medical device (abstract, surgical implant), comprising a metal substrate (abstract, substrate, [0022]) and a cladding layer ([0029], top layer of multilayer coating); wherein the cladding layer is a nickel-free and cobalt-free metal layer (abstract, Ti/TiZr) and is deposited on the metal substrate by metal bonding (for example [0022-0031]).
Regarding claim 2, Sequeda further teaches wherein a density of the cladding layer is greater than a density of the metal substrate (see substrate can be made of Ti 64 [0022] which has a density of about 4.43 g/cm³ and cladding can be TiZr [0029] which has a density of about 5.23 g/cm³ which is greater than the substrate).
Regarding claim 3, Sequeda further teaches wherein a thickness of the cladding layer is less than or equal to 25 Um ([0029], 550 nm is less than 25000 nm or 25 um).
Regarding claim 5, Sequeda further teaches wherein the implantable medical device further comprises at least one reinforcing layer deposited between the metal substrate and the cladding layer ([0029], bottom layer of multilayer coating) by metal bonding ([0022-0031]).
Regarding claim 7, Sequeda further teaches wherein a material of the reinforcing layer is selected from at least one of a metal element, a metal alloy, a metal oxide, or a metal nitride ([0029], metal nitride).
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) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sequeda (US 20160122865 A1) in further view of Castro (US 20110305819 A1).
Regarding claim 4, Sequeda further teaches wherein the material of the cladding layer is selected from at least one of a metal element or a metal alloy ([0029], metal alloy). Sequeda does not exactly teach wherein the metal element is Ir, Pt, Ru, Ta, W or Au or the metal alloy comprises at least one of PtIr, PtPd, or PtRh. Castro teaches a medical implant coating (abstract) wherein the metal element is Ir, Pt, Ru, Ta, W or Au ([0076], for example gold]); or the metal alloy comprises at least one of PtIr, PtPd, or PtRh ([0076], for example platinum-iridium).
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 device taught by Sequeda by applying the teaching of cladding layer material options, as taught by Castro, in order to combine known prior art elements, such as a multilayer coating and desired metals or metal alloy compositions, according to known methods to yield predictable results of a biocompatible coating with desired metal properties (MPEP 2143).
Claim(s) 6 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sequeda (US 20160122865 A1) in further view of Miller (CN 101978472 A).
Regarding claim 6, Sequeda does not exactly teach wherein a total thickness of the reinforcing layer is less than or equal to 500 nm. Miller teaches a biocompatible coating (abstract) wherein a total thickness of the reinforcing layer is less than or equal to 500 nm ([0038]).
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 device taught by Sequeda by applying the teaching of a different coating thickness, as taught by Miller, in order complete a simple substitution of one known coating thickness for another to obtain predictable results of a thinner biocompatible coating (MPEP 2143).
Regarding claim 20, Sequeda does not exactly teach wherein the reinforcing layer contains hydroxyl groups. Miller teaches a biocompatible coating (abstract) wherein a reinforcing layer contains hydroxyl groups ([0015]).
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 device taught by Sequeda by applying the teaching of a hydroxyl group inclusion, as taught by Miller, in order to combine known prior art elements, such as a multilayer coating with a hydroxyl group, according to known methods to yield predictable results of a biocompatible coating with desired hydroxyl properties (MPEP 2143).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sequeda (US 20160122865 A1) in further view of Castro (US 20110305819 A1) and Miller (CN 101978472 A).
Regarding claim 8, Sequeda further teaches wherein the metal nitride comprises at least one of TiN or TaNx ([0029], TiN). Sequeda does not exactly teach wherein the metal element is Ir, Pt, Ru, Ta, W or Au or the metal alloy comprises at least one of PtIr, PtPd, or PtRh. Castro teaches a medical implant coating (abstract) wherein the metal element is Ir, Pt, Ru, Ta, W or Au ([0076], for example gold]); or the metal alloy comprises at least one of PtIr, PtPd, or PtRh ([0076], for example platinum-iridium).
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 device taught by Sequeda by applying the teaching of cladding layer material options, as taught by Castro, in order to combine known prior art elements, such as a multilayer coating and desired metals or metal alloy compositions, according to known methods to yield predictable results of a biocompatible coating with desired metal properties (MPEP 2143).
Sequeda in view of Castro doesn’t exactly teach a metal oxide composition. Miller teaches a biocompatible coating (abstract) the metal oxide comprises at least one of HfO2, TiO2, Ta205, ZnO, ZrO2, MgO, SrTiOx, La203, or CeO2 ([0029]);
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 device taught by Sequeda in view of Castro by applying the teaching of different cladding layer material options, as taught by Miller, in order to combine known prior art elements, such as a multilayer coating and desired material compositions, according to known methods to yield predictable results of a biocompatible coating with desired metal oxide properties (MPEP 2143).
Claim(s) 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sequeda (US 20160122865 A1) in further view of Castro (US 20110305819 A1) and Tedeschi (DE 69932903 T2).
Regarding claim 9, Sequeda in view of Castro does not exactly teach the cladding layer hydroxyl group. Tedeschi teaches a medical coating (abstract) wherein the cladding layer (pg. 8 paragraph 4, coating) contains hydroxyl groups (pg. 8 paragraph 4).
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 device taught by Sequeda in view of Castro by adding a hydroxyl group to the cladding layer, as taught by Tedeschi, in order to combine known prior art elements according to known methods to yield predictable results of a biocompatible coating with hydroxyl properties (MPEP 2143).
Regarding claim 10, Sequeda in view of Castro does not exactly teach the cladding layer hydroxyl group. Tedeschi teaches a medical coating (abstract) wherein a mass fraction of the hydroxyl groups is less than or equal to 0.5% (pg. 8 paragraph 5).
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 device taught by Sequeda in view of Castro by adding a hydroxyl group to the cladding layer, as taught by Tedeschi, in order to combine known prior art elements according to known methods to yield predictable results of a biocompatible coating with hydroxyl properties (MPEP 2143).
Conclusion
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/H.L.P./Examiner, Art Unit 3774
/YASHITA SHARMA/Primary Patent Examiner, Art Unit 3774