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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 4, 5, 6, 7, 8. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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.
Specification
The disclosure is objected to because of the following informalities: Reference characters 4, 5, 6, 7, 8 from Figs. 2-6 are not mentioned in the description.
Appropriate correction is required.
Claim Objections
Claim 1 is objected to because of the following informalities: In line 5, “relative density varied” is assumed to be a typo. The examiner suggests amending this limitation to “relative density varies” and has been examined as such. 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 1-6 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.
Claims 1-6 are narrative in form and replete with indefinite language. The structure which goes to make up the device must be clearly and positively specified. The structure must be organized and correlated in such a manner as to present a complete operative device. The claim(s) must be in one sentence form only. Note the format of the claims in the patent(s) cited.
Claim 1 recites the limitations: "The TPMS structures" in lines 2-3 and “their relative density” in lines 4-5. There is insufficient antecedent basis for these limitations in the claim. Line 3 further recites the phrase “may include” which renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention.
Claim 6 recites the limitations: "the combination of the samples could also include the description" in lines 4-5. There is insufficient antecedent basis for these limitations in the claim. Lines 4-5, further recites the phrase “could also include the description of Claim (2)-Claim (5)” which renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention.
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 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Wen et al. (Foreign Patent No. CN 113326588 A) in view of Miller et al. (US Patent No. 10,772,732 B1).
Regarding claim 1, Wen discloses porous-based bone implants (See attached translation Paragraph [0002]), which were designed using Triply Periodic Minimal Surface, TPMS (See attached translation Paragraph [0002]). The TPMS structures may include Primitive, Gyroid (See attached translation Paragraph [00069]), Diamond, Neovius, FRD, IWP, and others, but fails to disclose in which their relative density varies from 0.1 to 1. Miller also discloses porous-based bone implants, which were designed using Triply Periodic Minimal Surface, TPMS (Col. 1, lines 52-65), and the TPMS structures may include Primitive, Gyroid, Diamond, Neovius, FRD, IWP, and others (Col. 5, lines 63-67, Col. 6, lines 1-5). Miller teaches in which their relative density varies from 0.1 to 1 (Col. 9, lines 59-62, Relative density varies inversely with porosity therefore it falls within the claimed range). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wen’s Triply Periodic Minimal Surface-based or TPMS-based bone implants in which their relative density varies from 0.1 to 1, as taught by Miller, in order to reduce the weight of the implant by increasing porosity (Col. 5, lines 51-54) which keeps the density low.
Regarding claim 2, Wen in view of Miller discloses Triply Periodic Minimal Surface-based or TPMS-based bone implants have constant (i) pore size, (ii) unit cell size, (iii) wall thickness, and (iv) relative density throughout the sample (See attached translation Paragraph [00069], same parameterization mathematical expression “cos (kx) sin (ky) + cos (ky) sin (kz) + cos (kz) sin (kx) = c” as present application).
Regarding claim 3, Wen in view of Miller discloses Triply Periodic Minimal Surface-based or TPMS-based bone implants have (i) pore size, (iii) wall thickness, and (iv) relative density, which are varied along the sample, while (ii) unit cell size is kept constant (See attached translation Paragraph [00069], same parameterization mathematical expression “cos (kx) sin (ky) + cos (ky) sin (kz) + cos (kz) sin (kx) = c” as present application, where the unit density p(x,y,z) constants are varied).
Regarding claim 4, Wen in view of Miller discloses Triply Periodic Minimal Surface-based or TPMS-based bone implants have (i) pore size, (iii) wall thickness, and (ii) unit cell size which are varied along the sample, while (iv) relative density is kept constant (See attached translation Paragraph [00069], same parameterization mathematical expression “cos (kx) sin (ky) + cos (ky) sin (kz) + cos (kz) sin (kx) = c” as present application, where the unit structure parameter c(x,y,z) constants are varied).
Regarding claim 5, Wen in view of Miller discloses Triply Periodic Minimal Surface-based or TPMS-based bone implants have (i) pore size, (ii) unit cell size, (iii) wall thickness, and (iv) relative density, which are varied along the sample (See attached translation Paragraph [00069], same parameterization mathematical expression “cos (kx) sin (ky) + cos (ky) sin (kz) + cos (kz) sin (kx) = c” as present application, where the unit density p(x,y,z) constants and the unit structure parameter c(x,y,z) constant are varied).
Regarding claim 6, Wen as modified by Miller fails to disclose Triply Periodic Minimal Surface-based or TPMS-based bone implants have the combination of two different TPMS structures in the single sample. The combination of the samples could also include the description of Claim (2)-Claim (5). Miller further teaches Triply Periodic Minimal Surface-based or TPMS-based bone implants have the combination of two different TPMS structures in the single sample (Col. 5, lines 63-67, Col. 6, lines 1-5). The combination of the samples could also include the description of Claim (2)-Claim (5) (Col. 5, lines 63-67, Col. 6, lines 1-5, same parameterization mathematical expressions as present application). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wen’s Triply Periodic Minimal Surface-based or TPMS-based bone implants to have the combination of two different TPMS structures in the single sample. The combination of the samples could also include the description of Claim (2)-Claim (5), as further taught by Miller, in order to have the function-based architectures needed for different properties needed in tissue engineering (Col. 5, lines 37-44).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Miller et al. (US Patent No. 11,484,413 B1) discloses porous-based bone implants, which were designed using Triply Periodic Minimal Surface, TPMS (Col. 2, lines 1-24), and the TPMS structures may include Primitive, Gyroid, Diamond (Col. 6, lines 8-20).
Harris et al. (US PG Pub No. 2023/0114676 A1) discloses porous-based bone implants (Fig. 1, interbody implant 100), which were designed using Triply Periodic Minimal Surface, TPMS (Paragraph [0007]), and the TPMS structures may include Gyroid (Paragraph [0007]).
Dong et al. (see attached NPL: Application of TPMS structure in bone regeneration) discloses porous-based bone implants, which were designed using Triply Periodic Minimal Surface, TPMS (Abstract), and the TPMS structures may include Primitive, Gyroid, Diamond, and IWP (Fig. 3A).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARI L COCHRAN whose telephone number is (571)272-9637. The examiner can normally be reached Monday-Thursday 7:00-5:00.
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/K.L.C./Patent Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774
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