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 .
Specification
The specification was received on 8 September 2025. This amended specification is acceptable.
The amended abstract was received on 8 September 2025. This amended abstract is not acceptable.
The abstract of the disclosure is objected to because of the use of legal phraseology, e.g., comprising. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 1, 2, 8 and 12 are objected to because of the following informalities: The claims include limitations between parenthesis. Due to any limitation within parenthesis is not given patentable weight, the values indicated for the thickness and the roughness out of the parenthesis are considered for examination. Appropriate correction is required.
Claim 4 is objected to because of the following informalities: In line 3 uses the term “surface” at the end of the claim. Even when the Office understands that said “surface” refers to the “surface of the layer”, other surfaces have been described in claim 1 that can create confusion. It is suggested to clarify the intended surface. Appropriate correction is required.
Claim 7 is objected to because of the following informalities: Even when the Office understands the claim refers that the implantable medical device is an “implant, in particular a dental implant, or a prosthesis, in particular a hip prosthesis, more specifically a cupula, a shoulder prosthesis, or a knee prosthesis”. In order to avoid confusion, it is suggested to indicate what the claim refers to, e.g., wherein the implantable medical device is an implant, in particular a dental implant, or a prosthesis, in particular a hip prosthesis, more specifically a cupula, a shoulder prosthesis, or a knee prosthesis. Appropriate correction is required.
Claim 8 is objected to because of the following informalities: In line 3 uses the terms “an implantable medical device”, “a layer comprising zirconia” and ”a thickness”. Even when the Office understands that said “implantable medical device” and said “layer” refers to the one described in claim 1, the term should read “thethethe. Appropriate correction is required.
Claim 12 is objected to because of the following informalities: The claim states three “wherein” clauses, the second “wherein” clause is used in combination with the word “and”, it is understood that based on the description, the second wherein is not the last statement in the claim.
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 1, 6-8, 11, 12, 14, 17 and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Breitenstein et al. (EP 1527790 A1).
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Regarding claim 1, Breitenstein et al. discloses an implantable medical device (1) (see Fig. 3 above and page 1, line 2 of the description - dental implant) including, over some of its surface, a layer (2) including zirconia, the layer (2) having a thickness of between 50 nm (± 10%) and 2000 nm (± 10%) (see page 3, line 33-41 – where zirconia is also known as zirconium oxide, and where the “coating is from 1nm to 1mm, preferably from 200 nm to 100 microns”, where Breitenstein includes the claimed range, and shares a portion of the range between 200 to 2000 nm (including the ± 10% around the upper and lower values) in its preferred range), wherein the layer includes, further to zirconia, at least one element or compound including calcium, located at least partially on the surface of the layer (see page 3, last paragraph – “for special applications but may also be gradual along the thickness of the ceramic coating a component are added, which, for example, the Soft tissue compatibility further improved, for example calcium”; due to it is added gradually along the thickness, it is understood that at least a portion is located at least partially on the surface of the layer).
Regarding claim 6, Breitenstein et al. discloses that the layer has a roughness Ra of between 0 and 4.0 mm (see page 4, lines 5-7 – ceramic coating including zirconium oxide has a roughness, “preferably from 100 nm to 5 mm”).
Regarding claim 7, Breitenstein et al. discloses that it is an implant, in particular a dental implant (see Fig. 3 and page 1, line 2 of the description - dental implant).
Regarding claim 8, Breitenstein et al. discloses a method for preparing an implantable medical device (1) according to claim 1, including a step of depositing, some of the surface of an implantable medical device, a layer (2) including zirconia, said layer having a thickness of between 50 nm (
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10%) and 2000 nm (10%) (see page 3, line 33-41 – where zirconia is also known as zirconium oxide, and where the “coating is from 1nm to 1mm, preferably from 200 nm to 100 microns”, where Breitenstein includes the claimed range, and shares a portion of the range between 200 to 2000 nm (including the ± 10% around the upper and lower values) in its preferred range), said deposition being carried out by physical vapour deposition (PVD) (see page 2, lines 18-19 – “Coatings can be applied by means of … PVD (physical vapor deposition)”) is:
(i) in the presence of a zirconium target and a target of at least one element including calcium (Ca) (see page 3, last paragraph – “for special applications but may also be gradual along the thickness of the ceramic coating a component are added, which, for example, the Soft tissue compatibility further improved, for example calcium”).
Regarding claim 11, Breitenstein et al. discloses that the at least one element of calcium (Ca) is deposited together with the zirconia (see page 3, last paragraph – “for special applications but may also be gradual along the thickness of the ceramic coating a component are added, which, for example, the soft tissue compatibility further improved, for example calcium).
Regarding claim 12, Breitenstein et al. discloses that wherein, prior to depositing the layer, the surface of the implantable medical device has a first roughness Ra (see page 3, lines 12-19 – where the “bone contact surface not provided with a ceramic coating is treated such that improved osteo-integration is effected” and “in this case, maximum roughness depths Rmax of 0.1 μm to 50 μm”), and wherein, after depositing the layer, the surface of the implantable medical device has a second roughness Ra (see page 4, lines 5-7 – ceramic coating including zirconium oxide has a roughness, “preferably from 100 nm to 5 mm”), and wherein the first roughness Ra and the second roughness Ra vary by less than or equal to 25% (± 10%) (when comparing the extension of the range of values of the roughness of the surface without the ceramic layer with the surface with the ceramic layer, it includes values in which the roughness can varies by less than or equal to 25%).
Regarding claim 14, Breitenstein et al. discloses that the layer has a thickness of between 500 nm (± 10%) and 800 nm (± 10%) (see page 3, line 33-41 – where zirconia is also known as zirconium oxide, and where the “coating is from 1nm to 1mm, preferably from 200 nm to 100 microns”, where Breitenstein includes the claimed range, and shares a portion of the range between 500 to 800 nm (including the ± 10%).
Regarding claim 17, Breitenstein et al. discloses that the layer has a roughness Ra ranging from 0.6 mm to 2.0 mm (see page 4, lines 5-7 – ceramic coating including zirconium oxide has a roughness, “preferably from 100 nm to 5 mm, where the claimed range is found in the range of Breitenstein).
Regarding claim 18, Breitenstein et al. discloses that the layer has a roughness Ra ranging from 1.0 mm to 1.5 mm (see page 4, lines 5-7 – ceramic coating including zirconium oxide has a roughness, “preferably from 100 nm to 5 mm”, where the claimed range is found in the range of Breitenstein).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 3 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Breitenstein et al. (EP 1527790 A1) as applied to claim 1 above, and further in view of Lim et al. (WO 2018190674 A1).
Regarding claim 3, Breitenstein discloses the claimed invention substantially as claimed, as set forth above for claim 1.
However, Breitenstein does not disclose that the zirconia is yttria zirconia, and/or partially or totally in its quadratic, cubic or monoclinic phase.
Lim et al. teaches ceramic coatings film for devices requiring antibacterial properties, where one of the ceramics is yttria zirconia used for its antibacterial properties (see [0030] — where it includes yttria-zirconia (YSA, Yttria stabilized zirconia), and yttria-zirconia is a cubic crystal structure).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the layer of zirconia of Breitenstein, with the yttria zirconia of Lim, in order to a medical device having a surface with antibacterial properties, in this way minimizing the generation of growth of microorganism in the implanted area.
Regarding claim 16, Breitenstein discloses the claimed invention substantially as claimed, as set forth above for claim 1.
However, Breitenstein does not disclose that the zirconia is yttria zirconia, that is at least partially monoclinic phase.
Lim et al. teaches ceramic coatings film for devices requiring antibacterial properties, where one of the ceramics is yttria zirconia used for its antibacterial properties (see [0030] — where it includes yttria-zirconia (YSA, Yttria stabilized zirconia), and yttria-zirconia is a cubic crystal structure).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the layer of zirconia of Breitenstein, with the yttria zirconia of Lim, in order to a medical device having a surface with antibacterial properties, in this way minimizing the generation of growth of microorganism in the implanted area.
Claims 4-5 and 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Breitenstein et al. (EP 1527790 A1) as applied to claim 1 above.
Regarding claim 4, Breitenstein discloses the claimed invention substantially as claimed, as set forth above for claim 1, and where Breitenstein discloses that calcium is located at least partially on the surface of the layer (see page 3, last paragraph – “for special applications but may also be gradual along the thickness of the ceramic coating a component are added, which, for example, the soft tissue compatibility further improved, for example calcium”; due to it is added gradually along the thickness, it is understood that at least a portion is located at least partially on the surface of the layer).
However, Breitenstein does not disclose that said element is over 10 to 30% of the surface.
On the other hand, due to Breitenstein discloses that the calcium is gradually applied along the thickness of the ceramic coating/layer, it is understood that it is a percentage of calcium added to the other components of the ceramic powder used to create the ceramic coating/layer.
However, this parameter is deemed matter of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results, in this case to increase the zirconia ceramic surface compatibility with the soft tissue surrounding it.
Regarding claim 5, Breitenstein discloses the claimed invention substantially as claimed, as set forth above for claim 1, and where Breitenstein discloses that in particular its surface, includes titanium, or in the form of an alloy (see [0012] – “Titanium or a titanium alloy is a preferred material for the base body of an implant according to the invention”).
However, Breitenstein does not disclose that the titanium being in particular grade 4 titanium, and that the alloy is in particular grade 5 titanium.
On the other hand, due to the materials are used in a dental implant application, said material should be corrosion resistance and should handle high forces. Therefore, it would be obvious for a person skill in the art to use grade 4 titanium, and grade 5 titanium for an alloy, in order withstand the constant humidity of the mouth without degrading, and to withstand the forces exposed and transferred to the implant during mastication and or occlusion.
Regarding claim 9, Breitenstein discloses the claimed invention substantially as claimed, as set forth above for claim 8, and where Breitenstein discloses the deposition of the layer (see page 2, lines 18-19 – “Coatings can be applied by means of … PVD (physical vapor deposition)”).
However, Breitenstein does not disclose that the physical vapour deposition is carried out by magnetron cathode spraying.
On the other hand, the use of the magnetron cathode spraying is implicit when it is used the PVD process. Therefore, it would be obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to assume that when using the physical vapour deposition process for depositing the material over the implantable medical device is used a magnetron cathode spraying.
Regarding claim 10, Breitenstein discloses the claimed invention substantially as claimed, as set forth above for claim 8.
However, Breitenstein does not disclose that implantable medical device is in rotation, or not, about at least one axis of rotation during all or some of the deposition.
On the other hand, due to said ceramic coating is placed around the medical device, for a person skill in the art would be obvious that either the implantable medical device turns around during the deposition or the sprayer turns around the implantable medical device during the application, because both alternatives are obvious possibilities that provides the same outcome, that in this case is the application of the ceramic material around the outer surface of the implantable medical device.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Breitenstein et al. (EP 1527790 A1) as applied to claim 8 above, and further in view Nishio et al. (US 4483678 A).
Regarding claim 13, Breitenstein discloses the claimed invention substantially as claimed, as set forth above for claim 8.
However, Breitenstein does not disclose that the at least one element or one compound includes at least one element chosen from among Mg, Ca, Ag, and Zn is deposited after the zirconia has been deposited.
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Nishio et al. teaches a dental implant including a coating layer of zirconia (2) over the body of the dental implant body, and over the layer of zirconia (2) it is cover a layer of a compound in the form of a slurry including calcium phosphate (3). Said calcium phosphate layer over the zirconia layer (2), when sintered, it provides pores having an average diameter of from 20 to 500m. Said layer provides pores that improve affinity between the implant and the bone (see annotated figure above and col. 3, lines 20-31).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the application of the calcium to the zirconia of Breitenstein, with the application of the calcium compound after the zirconia layer is placed of Nishio, in order to create pores on the surface that improves the affinity of the surrounding cells, in this way improving cell attachment to the final layer of the implant.
Allowable Subject Matter
Claim 15 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 15, the prior arts of Breitenstein, Lim and Nishio do not disclose individually or in combination that the layer has, over a part of the surface of said device, a thickness of between 50 nm (± 10%) and 1200 nm (± 10%), and over another part of the surface of said device, a thickness of between 800 nm (± 10%) and 2000 nm (± 10%).
Response to Arguments
Applicant’s arguments with respect to claims 1-12 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Regarding claim 1, the language used in the amendment to the claim to narrow down the thickness of the subject matter, has changed the interpretation of the claimed implantable medical device that was rejected in the last Office action of 6 June 2025.
However, after a further search, it was found the prior art of Breitenstein including the claimed subject matter of at least claim 1.
Furthermore, the prior art of Breitenstein and in combination of the prior arts of Lim and Nishio described the subject matter of claims 2-14, and 16-18, making the present set of claims not ready for allowance.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MIRAYDA ARLENE APONTE whose telephone number is (571)270-1933. The examiner can normally be reached M-F 8-5.
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/MIRAYDA A APONTE/Examiner, Art Unit 3772 /ERIC J ROSEN/Supervisory Patent Examiner, Art Unit 3772