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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 3-6 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.
In claim 3, applicants claim “…wherein the mass fraction of the ethyl orthosilicate is 28%...and a mass fraction of the aqueous ammonia is 25-28%...”.
It is unclear as to what the “mass fraction” means in this sense, as applicants then claim the volumetric ratio of components in the sol gel process, where a range is not the same as “28%”.
It is noted that since claims 4-6 ultimately or directly depend from claim 3, they are rejected along with claim 3 because they incorporate all of the limitations of claim 3, including those that are indefinite.
Claim Objections
Claims 1, 2, 4 and 5 are objected to because of the following informalities:
The claims are objected to because they include the following reference characters which are not enclosed within parentheses: S1, S2, S3 and S4 in claim 1 and S21, S22 and S23 in instant claim 4.
Reference characters corresponding to elements recited in the detailed description of the drawings and used in conjunction with the recitation of the same element or group of elements in the claims should be enclosed within parentheses so as to avoid confusion with other numbers or characters which may appear in the claims. See MPEP § 608.01(m).
Appropriate correction is required.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 7-9 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by CN 115782154; however, for convenience, the machine translation will be cited below.
CN ‘154 discloses a hot pressed PEK material obtained by hot pressing silicon dioxide nanoparticles into PEEK and then removing the silicon dioxide to obtain a surface with micro-nano structure.
Claims 7-8 define the product by how the product was made. Thus, claim7-8 are a product-by-process claims. For purposes of examination, product-by-process claims are not limited to the manipulation of the recited steps, only thestructure implied by the steps. See MPEP 2113. In the present case, the recitedsteps imply a PEEK structure with nano-concave impressions on the surface.
The reference suggests such a product. Additionally, the silicon dioxide nanoparticles have the same size as that described by the instant invention; therefore, the PEEK modified structure inherently possesses the claimed nanostructure.
As to claim 9, CN ‘154 exemplifies preparing bone implants with the modified PEEK.
Claim Rejections - 35 USC § 103
Claims 1-3 and 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over CN 115782154; however, for convenience, the machine translation will be cited below.
CN ‘154 teaches preparing silicon dioxide nanoparticles (Embodiments 1-3) and coating a PEEK wafter with the silicon dioxide nanoparticles, heating to 150°C, where the Tg of PEEK is about 145°C and hot pressing, and then using NaOH to remove the silicon dioxide to obtain the PEEK material with interface micro-nanostructure.
While CN ‘154 does not specifically teach cooling the hot pressed PEEK to room temperature before treating with the NaOH; however, NaOH is known to be very volatile at high temperatures. Therefore, one of ordinary skill in the art would find it obvious to allow the hot pressed PEEK to cool to room temperature before treating with NaOH to reduce the possibility of the NaOH vaporizing due to the high temperatures used for pressing.
CN ‘154 is prima facie obvious over instant claim 1.
As to claims 2-3, CN ‘154 exemplifies preparing the silicon dioxide by mixing ethanol, water and aqueous ammonia (25-28%) in a volume ratio of 6:6:1, then adding ethyl orthosilicate at volume ratio with the ammonia water of 5:1, suggesting a volume ratio as claimed of 6:6:1:1.2, reacting for 2 hours, and obtaining silicon dioxide nanospheres with a diameter of 100-800 nm.
Claims 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over CN 115782154 in view of Leo (US 2020/0110037).
CN ‘154 is prima facie obvious over instant claims 1-3, 5 and 6, as described above and applied herein as such, as CN ‘154 teaches preparing silicon dioxide nanoparticles, coating a PEEK wafter with the silicon dioxide nanoparticles, heating to 150°C, where the Tg of PEEK is about 145°C and hot pressing, and then using NaOH to remove the silicon dioxide to obtain the PEEK material with interface micro-nanostructure.
As to claim 4, CN ‘154 teaches preparing an ethanol solution of the prepared silicon dioxide nanoparticles, cleaning the PEEK with acetone, ethanol and water, and then “paving” or coating the silicon dioxide nanoparticles to the PEEK substrate material; however, CN ‘154 does not teach film-drawing using the ethanol solution of the silicon dioxide by way of the Langmuir-Blodgett film-drawing machine, as claimed.
Leo teaches that a silica nanoparticle monolayer can be used as a structural template for fabricating microporous polymer membranes, where self-assembled silica nanoparticle monolayers can be created by a variety of methods, for example a simple and scalable Langmuir-Blodgett method (p. 4, [0058]). This is a method similarly desired by CN ‘154; therefore, using the Langmuir-Blodgett method to coat the PEEK substrate of CN ‘154 is prima facie obvious, as Leo teaches that this method is a simple and scalable method for forming monolayers of silica nanoparticles.
As to the concentration of silica in the ethanol solution, one of ordinary skill in the art would be able to determine the desired concentration for the coating solution dependent on the amount of microporous structures desired on the PEEK substrate/implant.
As to claim 5, CN ‘154 teaches hot pressing at 140-150°C for 10-20 minutes. CN ‘154 does not teach the pressure of hot pressing; however, one of ordinary skill would be able to determine the desired pressure for pressing the silicon dioxide into the PEEK based on the temperature for pressing and the desired depth for creating the nanostructures.
As to claim 6, CN ‘154 teaches the NaOH solution as 5 mol/L, or about 5.5 mol/kg (molality).
Claims 1 and 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over JP 2009-034904 in view of JP 2005-230947. The machine translations of JP ‘904 and JP ‘947 are cited below.
JP ‘904 teaches a surface-treated substrate having fine irregularities on a surface, prepared by applying a fine particle dispersion on the surface of the resin film, forming a fine particle deposition layer by drying the applied dispersion, mechanically embedding the fine particle deposition layer in the resin film, forming a porous layer by removing the final particle deposition layer.
JP ‘904 teaches that the fine particles can include silica fine particles and the resin film can include polyether ether ketones, also known as PEEK. JP ‘904 teaches that the fine particles can have a diameter of 0.01-10 micron, preferably 0.1-1 micron (or 100 to 1000 nm).
JP ‘904 teaches mechanically embedding the fine particle deposition layer in the resin film by way of hot pressing, teaching that the unevenness of the fine particle deposition layer can be more accurately transferred to the resin film surface by embedding the fine particle deposition layer by applying pressure while softening the resin film. The Tg of a polymer is known as its softening point. Therefore, heating to a Tg of the polymer is necessary to soften the resin film and is prima facie obvious.
JP ‘904 teaches that the silica can be removed by way of hydrofluoric acid, but does not teach NaOH for removal, as claimed.
JP ‘904 mentions JP ‘947 in the background section for embedding fine particles in a support substrate. JP ‘947 teaches embedding silica particles, which are then removed by way of dissolution in aqueous sodium hydroxide (Example 1).
Therefore, choosing sodium hydroxide to dissolve the silica is prima facie obvious, as JP ‘904 mentions JP ‘947 as a prior art reference and JP ‘947 teaches that sodium hydroxide can also be used to dissolve silica.
While JP ‘904 does not specifically teach cooling the hot pressed resin film to room temperature before treating with the NaOH, NaOH is known to be very volatile at high temperatures. Therefore, one of ordinary skill in the art would find it obvious to allow the hot pressed resin film to cool to room temperature before treating with NaOH to reduce the possibility of the NaOH vaporizing due to the high temperatures used for pressing.
JP ‘904 in view of CN ‘994 is prima facie obvious over instant claims 1 and 7-8.
As to claim 2, JP ‘904 teaches the silica as preferably colloidal silica, which is known in the art as being prepared in the art by way of sol-gel, which uses an ammonia solution to hydrolyze ethyl silicate, also known as tetraethyl orthosilicate.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIEANN R JOHNSTON whose telephone number is (571)270-7344. The examiner can normally be reached Monday-Friday, 8:00 AM - 4:00 PM EST.
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/Brieann R Johnston/ Primary Examiner, Art Unit 1766
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