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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
The claim to priority filled on 01/27/2023 acknowledged in the instant application.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/27/2023 and 08/09/2024 in compliance with the provisions of 37 CFR 1. 97. Accordingly, the information disclosure statement has been considered by the examiner.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
The specification is objected to as using phrases which can be implied. See MPEP § 608.01(b) I. C. Language and Format. The phase “The present invention addresses the problem of providing a plasma spraying material with which it is possible to form an HAp film that has high hardness and is not susceptible to abrasion, even under conditions involving plasma spraying with low flame energy” under Abstract are objected, because the phase can be implied. Appropriate correction is required.
Claim Rejections – 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 6-11 are rejected under 35 U.S.C. 101 because the phrase “to be used” without setting forth any active method steps in claims 6 and 7; these claims are synonymous with the phrase “A method of using the plasma spraying material of claim 1” (see MPEP 2173.05(q)).
the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because Claim 6 recites the limitation “the plasma spraying material to be used for plasma spraying in which a gas consisting of one or more kinds of monatomic molecules as a working gas” and Claim 7 recites the limitation “the plasma spraying material to be used for film formation on a substrate”.
Therefore, each claim is not patent eligible and rejected under 35 U.S. C. 101.
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.
Claims 5-16 are rejected under 35 U.S.C. 112(b) 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 pre-AIA the applicant regards as the invention.
Claim 5 recites the limitation “a pore volume” in line 2 rendering the claim indefinite because it is unclear what the relation between this “a pore volume” and a pore volume mentioned in claim 1 line 2 are? Appropriate correction/ clarification is required.
Claim 5 recites the limitation “a pore size” in line 2 rendering the claim indefinite because it is unclear what the relation between this “a pore size” and a pore size mentioned in claim 1 line 3 are? Appropriate correction/ clarification is required.
Claim 6 recites the limitation “the plasma spraying material to be used for plasma spraying in which a gas consisting of one or more kinds of monatomic molecules as a working gas” rendering the claim indefinite because the claim attempts to claim a process without setting forth any steps involved in the process and raises an issue of indefiniteness (see MPEP 2173.05(q)). Appropriate correction/ clarification is required.
Claim 6 recites the limitation “a gas consisting of one or more kinds of monatomic molecules” in line 2 rendering the claim indefinite. The transitional phase “consisting of” define the scope of a claim with respect to what unrecited additional components or steps, if any, are excluded from the scope of the claim (see PMEP 2111.03); which therefore requires a closed group of alternatives, which is often used in claim drafting to signal a Markush group by its nature closed, it is unclear what this “one or more kinds monatomic molecules” stands for. For examination purposes, examiner interprets “a gas consisting of one or more kinds of monatomic molecules” as "a gas consisting of monatomic molecules”.
Claim 7 recites the limitation “the plasma spraying material to be used for film formation on a substrate” rendering the claim indefinite because the claim attempts to claim a process without setting forth any steps involved in the process and raises an issue of indefiniteness (see MPEP 2173.05(q)). Appropriate correction/ clarification is required.
Claim 9 recites the limitation “the material” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation “the material” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites the limitation “a hydroxyapatite film” in line 3 rendering the claim indefinite because it is unclear what the relation between this “a hydroxyapatite film” and a hydroxyapatite film mentioned in line 1 are? Appropriate correction/ clarification is required.
Claim 13 recites the limitation “a hydroxyapatite film” in line 1 rendering the claim indefinite because it is unclear what the relation between this “a hydroxyapatite film” and a hydroxyapatite film mentioned in claim 12 line 1 are? Appropriate correction/ clarification is required.
Claim 14 recites the limitation “a hydroxyapatite film” in line 1 rendering the claim indefinite because it is unclear what the relation between this “a hydroxyapatite film” and a hydroxyapatite film mentioned in claim 12 line 1 are? Appropriate correction/ clarification is required.
Claim 14 recites the limitation “the material” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 15 recites the limitation “a hydroxyapatite film” in line 1 rendering the claim indefinite because it is unclear what the relation between this “a hydroxyapatite film” and a hydroxyapatite film mentioned in claim 12 line 1 are? Appropriate correction/ clarification is required.
Claim 15 recites the limitation “the material” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 recites the limitation “a hydroxyapatite film” in line 1 rendering the claim indefinite because it is unclear what the relation between this “a hydroxyapatite film” and a hydroxyapatite film mentioned in claim 12 line 1 are? Appropriate correction/ clarification is required.
The rest of the claims are also been rejected because each claim depends on a rejected claim.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS— Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 5 and 8-11 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 5 recites “a pore volume of 0.20 to 0.80 cc/g at a pore size of 2000 nm or more" appears to be a replacement of the limitations under claim 1. As such, claim 5 are not a further limitation of the subject matter claimed. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claims 8-11 neither define a method with active steps, nor further define the claimed plasma spraying material in claim 1. Therefore, claims 8-11 fail to further limit claim 7. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
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 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.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-13 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over BAST AN, F. E. et al., (Spray drying of hydroxyapatite powders: The effect of spray drying parameters and heat treatment on the particle size and morphology, Journal of Alloys and Compounds, 10 July 2017, vol. 724, pp.586-596).
Regarding Independent Claim 1, BAST AN, F. E. et al. discloses a plasma spraying material comprising a hydroxyapatite powder (see Title and Introduction) having an average particle size (D50) of 15 to 40 μm (see details in Table 4 at P 6/11: D50 within a range of 38.47-31.67, shown between 750 0C and 1500 0C) and, as measured by mercury porosimetry, a pore volume of 0.01 to 0.30 cc/g at a pore size of 2000 nm or less (pore volume within a range of 0.35006-0.00027 and details in Table 4 and Fig. 6A at P 6/11: pore size of 2000 nm or less; all shown between 750 0C and 1500 0C, details in Table 4 and Fig 6A; see MPEP 2112.01 II).
Therefore, it would have been obvious before the effective filling date of the claimed invention to one of ordinary skill in the art to modify BAST AN, F. E. et al. with further teaching of a plasma spraying material comprising a hydroxyapatite powder having an average particle size (D50) of 15 to 40 μm and, as measured by mercury porosimetry, a pore volume of 0.01 to 0.30 cc/g at a pore size of 2000 nm or less; because BAST AN, F. E. et al. teach, introduction, of providing an excellent plasma spraying material with the reliability and the long time survivability of the coating with high adhesive bond strength to metallic substrates.
Claim 2, wherein the pore volume is 0.01 to 0.25 cc/g (see details in Table 4 at P 6/11: pore volume within a range of 0.35006-0.0027, shown between 750 0C and 1500 0C). BAST AN, F. E. et al. do not explicitly disclose the limitations as claimed; however, a person skilled in the art could have arrived the values of the pore volume by adjusting the heat treatment temperature within the range of 750-1000°C as shown in Table 4, that makes it capable to achieve the recited limitations as claimed.
Claim 3, wherein the average particle size (D50) is 20 to 40 μm (see details in Table 4 at P 6/11: D50 within a range of 38.47-31.67, shown between 750 0C and 1500 0C). BAST AN, F. E. et al. do not explicitly disclose the limitations as claimed; however, a person skilled in the art could have arrived the values of the average particle size by adjusting the heat treatment temperature within the range of 750-1000°C as shown in Table 4, that makes it capable to achieve the recited limitations as claimed.
Claim 4, wherein the hydroxyapatite powder has a BET specific surface area of less than 5 m2/g (0.1638 m2/g, 1000°C as shown in Table 4 at P 6/11).
Claim 5, wherein the hydroxyapatite powder has a pore volume of 0.20 to 0.80 cc/g at a pore size of 2000 nm or more as measured by mercury porosimetry (see details in Table 4 at P 6/11: pore volume within a range of 0.35006-0.0027 and details in Fig. 6A at P 6/11: a pore size; all shown between 750 0C and 1500 0C).
Claim 6, the plasma spraying material to be used for plasma spraying (see Title and Introduction) in which a gas consisting of one or more kinds of monatomic molecules as a working gas (Note: claim 6 is a use claim and there is nothing prohibiting the plasma spraying material from being use with “a gas consisting of one or more kinds of monatomic molecule as a working gas” as claimed).
Claim 7, the plasma spraying material to be used for film formation on a substrate (Note: claim 7 is a use claim and there is nothing prohibiting the plasma spraying material from being use for “film formation on a substrate” as claimed).
Claim8, wherein a material of the substrate is a resin, a metal, or a ceramic (Note: claim 8 is a use claim and there is nothing prohibiting the plasma spraying material from being use with “a material of the substrate is a resin, a metal, or a ceramic” as claimed).
Claim 9, wherein the material of the substrate is a polyether ether ketone (Note: claim 9 is a use claim and there is nothing prohibiting the plasma spraying material from being use with “the material of the substrate is a polyether ether ketone” as claimed).
Claim 10, wherein the material of the substrate is a titanium alloy (Note: claim 10 is a use claim and there is nothing prohibiting the plasma spraying material from being use with “the material of the substrate is a titanium alloy” as claimed).
Claim 11, wherein the substrate is an implant (Note: claim 11 is a use claim and there is nothing prohibiting the plasma spraying material from being use with “the material substrate is an implant” as claimed).
Claim 12, a method for forming a hydroxyapatite film, the method comprising plasma-spraying the plasma spraying material according to claim 1 to form a hydroxyapatite film on a substrate (spray drying of hydroxyapatite powders, see Title; it is frequently deposited on metallic implants, Introduction, P 1/11).
Claim 13, the method for forming a hydroxyapatite film according to claim 12, wherein a material of the substrate is a resin, a metal, or a ceramic (it is frequently deposited on metallic implants, Introduction, P 1/11.).
Claim 16, The method for forming a hydroxyapatite film according to claim 12, wherein the substrate is an implant (it is frequently deposited on metallic implants, P 1/11.).
Claim 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over BAST AN, F. E. et al., in view of KITAMURA et al. (US 2020/0347239 A1).
Regarding Claim 14, BAST AN, F. E. et al. teach the invention as claimed and as discussed above; except does not disclose Claim 14.
KITAMURA et al. teach a method for forming a hydroxyapatite film, the method comprising plasma-spraying the plasma spraying material (a plasma spray material which is capable of forming a hydroxyapatite, Abstract), and Claim 14, The method for forming a hydroxyapatite film according to claim 12, wherein the material of the substrate is a polyether ether ketone (a material of a substrate on
which a HAp film is to be formed… include metals such as… polyether ether ketone, [0076]). Therefore, it would have been obvious before the effective filling date of the claimed invention to one of ordinary skill in the art to modify BAST AN, F. E. et al. with KITAMURA et al.’s further teaching of Claim 14; because KITAMURA et al. teach, in Abstract, of providing an excellent method with a plasma spray material which is capable of forming a hydroxyapatite film that exhibits high adhesion strength with respect to substrates such as metal substrates.
Claim 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over BAST AN, F. E. et al., in view of ISHIBASHI (JP 2003 325553 A).
Regarding Claim 15, BAST AN, F. E. et al. teach the invention as claimed and as discussed above; except does not disclose Claim 15.
ISHIBASHI teaches a method for forming a hydroxyapatite film, the method comprising plasma-spraying the plasma spraying material (using a plasma spraying method, [0001]), and Claim 15, The method for forming a hydroxyapatite film according to claim 12, wherein the material of the substrate is a titanium alloy (include
metal materials such as titanium, titanium alloys, [0005]). Therefore, it would have been obvious before the effective filling date of the claimed invention to one of ordinary skill in the art to modify BAST AN, F. E. et al. with ISHIBASHI’s further teaching of Claim 15; because ISHIBASHI teaches, in Para. [0005], of providing an excellent method with material of titanium alloys because of the biocompatibility, strength, and the ability to form a coating layer.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Applicant is advised to refer to the Notice of References Cited for pertinent prior art. Any inquiry concerning this communication or earlier communications from the examiner should be directed to KUANGYUE CHEN whose telephone number is 571/272-8224. The examiner can normally be reached on M-F 9:00-5:00 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, supervisor Ibrahime Abraham can be reached on 571/270-5569, supervisor Kosanovic Helena can be reached on 571/272-9059, supervisor Steven Crabb can be reached on 571/270-5095, or supervisor Edward Landrum can be reached on 571/272-5567. The fax phone number for the organization where this application or proceeding is assigned is 571/273-8300.
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/KUANGYUE CHEN/
Examiner, Art Unit 3761
/EDWARD F LANDRUM/Supervisory Patent Examiner, Art Unit 3761