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 .
Election/Restrictions
Applicant’s election without traverse of Group III in the reply filed on 12/12/2025 is acknowledged. Claims 1-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/12/2025. The requirement is deemed proper and is therefore made FINAL.
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 18, 19, and their dependent claims 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. Claim 18 recites “the simulated characteristic of the orthopedic implant design comprises finding an extremum of a function based, at least in part on an osseointegration performance score and a stress-shielding prevention performance score.” As presently worded, it is unclear what type of function based element the claim is intending to recite. Claim 19 recites “the numerical representation comprises an assembly of meso-lattice cells attached to one another.” It is unclear how meso-lattice cells are intended to provide “numerical representation.” Appropriate correction and/or clarification 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.
Claim(s) 16-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pasini et al. (WO 2013/091085 A1; hereinafter “Pasini”).
Pasini discloses the following regarding claim 16: a system for creating a patient-specific orthopedic implant (paras. 0010-0012), comprising: a computer processor (paras. 0053-0057, 0065, 0109) configured to: create a numerical representation of an orthopedic implant design (paras. 0010-0012) based, at least in part, on patient data describing an anatomical, physiological and pathological condition of a patient (paras. 0043-0053, 0061-0063), optimize a simulated characteristic of the orthopedic implant design by varying a value of at least one parameter of the numerical representation (paras. 0010-0012, 0043-0053, 0056-0058, 0065), select a patient-specific orthopedic implant design based, at least in part, on the simulated characteristic of the orthopedic implant design and the patient data (paras. 0010-0012, 0043-0053); and an additive manufacturing machine, configured to manufacture at least one patient-specific orthopedic implant using an additive manufacturing material based, at least in part, on the selected patient-specific orthopedic implant design (paras. 0047, 0075-0079, 0083).
Pasini discloses the following regarding claim 17: the system of claim 16, wherein the additive manufacturing machine is further configured to coat a surface of the at least one manufactured patient-specific orthopedic implant with an osteoblast-inducing substance (para. 0081).
Pasini discloses the following regarding claim 18: the system of claim 16, wherein optimizing, the simulated characteristic of the orthopedic implant design comprises finding an extremum of a function based, at least in part on an osseointegration performance score and a stress-shielding prevention performance score (paras. 0041-0048, 0073-0093; the claim is being interpreted to mean that the optimizing step comprises using potential maximum values of osseointegration and stress-shielding to be included in a function based equation).
Pasini discloses the following regarding claim 19: the system of claim 16, wherein the numerical representation comprises an assembly of meso-lattice cells attached to one another (Fig. 4, where the numerical representation is being interpreted to mean the number of cells used at a meso-level construction of the implant), wherein each meso-lattice cell is formed from an assembly of unit lattice cells (microstructure unit cells) attached to one another (Fig. 2B; paras. 0010-0012, 0040-0042, 0067-0068, 0090-0093).
Pasini discloses the following regarding claim 20: the system of claim 16, wherein the additive manufacturing material is selected from the group comprising β tri-calcium phosphate, medical-grade titanium alloy, titanium-64, tantalum, cobalt-chrome, and polyether ether ketone (para. 0083).
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) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pasini in view of Pawar et al (US Pat. No. 10,279,521 B1; hereinafter “Pawar”).
Pasini discloses the limitations of the claimed invention, as described above. However, it does not explicitly recite optimizing the simulated characteristic of the orthopedic implant design by applying artificial intelligence techniques. Pawar teaches that it is well known in the art that artificial intelligence is used in optimizing an orthopedic implant (col. 20, lines 44-col. 21, lines 18), for the purpose of utilizing the operations to develop an improved implant design that will best fit a patient. It would have been obvious to one having ordinary skill in the art to modify the invention of Pasini to include artificial intelligence techniques, as taught by Pawar, in order to develop an improved implant design that will best fit a patient. Such a modification would be made with a reasonable expectation of success.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ann Hu whose telephone number is (571) 272-6652. The examiner can normally be reached on Monday-Friday (9:00 am-5:30 pm EST).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Jerrah Edwards, at (408) 918-7557. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/ANN HU/Primary Examiner, Art Unit 3774