DETAILED ACTION
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 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 10 and 20 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 10 and 20 contain the limitation, “[Equation 1]” “[Equation 1]” does not appear in the body of the claim since it’s after the period. Please correct by inserting the equation into the body of the claim. Appropriate corrections are required.
Claim 20 contains the limitation “Equation 1. It is unclear to the examiner what “Equation 1” is referring to. Please place Equation 1 from Claim 10 into Claim 20. 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 1 and 11 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Cengiz et al. “Building the basis for patient-specific meniscal scaffolds: From human knee MRI to fabrication of 3D printed scaffolds” Bioprinting 1-2 (2016) p 1-10 dated 20 May 2016 hereinafter referred to as Cengiz.
As per Claim 1, Cengiz teaches an apparatus for predicting a 3D shape of a patient-tailored implant, comprising:
a memory configured to store at least one instruction for predicting the 3D shape of the patient-tailored implant; and and (Cengiz, p3, Section 2.1 MRI segmentation and 3D model reconstruction of the human meniscus tissue and 2.2. Fabrication of patient-specific meniscal scaffolds, “Our 3D model generation process involved four main steps… The fabrication process of the patient-specific meniscal scaffolds has three main steps”)
a processor configured to execute an operation according to the instruction,
wherein the processor is configured to: model a correlation between a 2D meniscus shape and a 3D meniscus shape; and (Cengiz, p2, Section 2.1 MRI segmentation and 3D model reconstruction of the human meniscus tissue, “Five healthy male volunteer subjects underwent static MRI scans with the use of a PET/MRI hybrid device…Our 3D model generation process involved four main steps…The segmentations were performed by a single operator using RheumaSCORE and then reviewed and validated by two experienced segmenters. The segmentation tool interface provides simultaneous 2D slice-by-slice visualization of original data, using different views, i.e. sagittal, coronal, and axial, segmentation results as well as the 3D surface rendering of the segmented elements. The segmentation process is user-driven, interactive and can iteratively converge to the desired outcome.”)
As per Claim 11, Claim 11 claims a method for predicting a 3D shape of a patient-tailored implant utilizing the apparatus as claimed in Claim 1. Therefore the rejection and is analogous to that made in Claim 1.
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 of this title, 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.
Claims 2, 6, 12 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Cengiz et al. “Building the basis for patient-specific meniscal scaffolds: From human knee MRI to fabrication of 3D printed scaffolds” Bioprinting 1-2 (2016) p 1-10 dated 20 May 2016 hereinafter referred to as Cengiz as applied to Claims 1 and 11 respectively and further in view of Linder-Ganz et al. US2011/0054486 hereinafter referred to as Linder-Ganz.
As per Claim 2, Cengiz teaches the apparatus of claim 1, wherein the processor is configured to: to determine the correlation between the 2D meniscus shape and the 3D meniscus shape; select 2D shape features that have a correlation between the measured 2D shape features and the 3D shape features above a predetermined level by performing a correlation analysis. (Cengiz, p2, Section 2.1 MRI segmentation and 3D model reconstruction of the human meniscus tissue, “Five healthy male volunteer subjects underwent static MRI scans with the use of a PET/MRI hybrid device…Our 3D model generation process involved four main steps…The segmentations were performed by a single operator using RheumaSCORE and then reviewed and validated by two experienced segmenters. The segmentation tool interface provides simultaneous 2D slice-by-slice visualization of original data, using different views, i.e. sagittal, coronal, and axial, segmentation results as well as the 3D surface rendering of the segmented elements. The segmentation process is user-driven, interactive and can iteratively converge to the desired outcome.” The threshold is such that the 2D slices used to build is used in the model)
Cengiz does not explicitly teach measure 2D meniscus shape features from 2D X-ray and 2D MRI images of an opposite, healthy knee of an identical patient and
Linder-Ganz teaches measure 2D meniscus shape features from 2D X-ray and 2D MRI images of an opposite, healthy knee of an identical patient and (Linder-Ganz, Paragraph [0069], “Referring now to FIGS. 6-9, shown therein are various views of a knee joint 280 based on MRI and/or CT scans identifying measurements of the anatomical features of the knee joint. It should be noted that while these measurements are described as being based on MRI and/or CT scans in some instances, it is understood that X-ray and/or other imaging techniques are also used in some instances in the context of the present disclosure” and Paragraph [0057], “In most healthy patient knees, the natural meniscus and the surrounding bone structures have substantially matching geometrical contours”)
Thus it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to implement the teachings of Linder-Ganz into Cengiz because by utilizing both MRI and X-Ray and also the use of the patient healthy knee will allow for accurate imaging for accurate 3D modeling for 3D printing of the menisci of the patient.
Therefore it would have been obvious to one of ordinary skill to combine the two references to obtain the invention in Claim 2.
As per Claim 6, Cengiz teaches the apparatus of claim 1,
Cegniz does not explicitly teach wherein the 2D shape features include at least one or more of anteroposterior (AP) length, mediolateral (ML) length, anterior horn-posterior horn (AH-PH) distance, medial femoral condylar (Med FC) length, lateral femoral condylar (Lat FC) length, and joint space in stress X-ray.
Linder-Ganz teaches wherein the 2D shape features include at least one or more of anteroposterior (AP) length, mediolateral (ML) length, anterior horn-posterior horn (AH-PH) distance, medial femoral condylar (Med FC) length, lateral femoral condylar (Lat FC) length, and joint space in stress X-ray. (Linder-Ganz, Paragraph [0069], “Referring more specifically to FIG. 6, a cross-sectional top view of the knee joint 280 identifying various measurements of the anatomical features is provided. In particular, the width of the meniscus as measured in the coronal plane (labeled MW) and the coronal tibia width (labeled TPW) are identified. These parameters are utilized for calculating the coronal relation as described below. Further, the tibia medial length (labeled ML) is identified along with the tibia medial perimeter (labeled TMP). Referring more specifically to FIG. 7, a cross-sectional top view of the knee joint 280 similar to that of FIG. 6, but identifying measurements of other anatomical features is provided. Specifically, the anterior and posterior meniscus widths (labeled MWA and MWP, respectively) are provided. Also, the medial meniscus length (labeled MML) and the meniscus perimeter (labeled P) are provided”)
Thus it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to implement the teachings of Linder-Ganz into Cengiz because by utilizing the above features from Linder-Ganz will result in accurate 3D modeling for 3D printing of the menisci of the patient.
Therefore it would have been obvious to one of ordinary skill to combine the two references to obtain the invention in Claim 6.
As per Claim 12, Claim 12 claims the same limitation as Claim 2 and is dependent on a similarly rejected independent claim. Therefore the rejection and rationale are analogous to that made in Claim 2.
As per Claim 16, Claim 16 claims the same limitation as Claim 6 and is dependent on a similarly rejected independent claim. Therefore the rejection and rationale are analogous to that made in Claim 6.
Claims 7 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Cengiz et al. “Building the basis for patient-specific meniscal scaffolds: From human knee MRI to fabrication of 3D printed scaffolds” Bioprinting 1-2 (2016) p 1-10 dated 20 May 2016 hereinafter referred to as Cengiz as applied to Claims 1 and 11 respectively and further in view of McCullen et al. US2017/0224498 hereinafter referred to as McCullen.
As per Claim 7, Cengiz teaches the apparatus of claim 1,
Cengiz does not explicitly teach wherein the 3D shape features include at least one or more of anteroposterior (AP) length, mediolateral (ML) length, anterior horn-posterior horn (AH-PH) distance, inner circumference, outer circumference, coverage area, and gap area.
McCullen teaches wherein the 3D shape features include at least one or more of anteroposterior (AP) length, mediolateral (ML) length, anterior horn-posterior horn (AH-PH) distance, inner circumference, outer circumference, coverage area, and gap area. (McCullen, Abstract, “An implant device used to replace and restore the function of the knee meniscus in a human. The compliant, yet resilient device is comprised of a biocompatible, non-degradable three-dimensional body comprised of at least a central body, a second structure, a third structure… The third structure further features a first and a second pulling element which is coupled to the central body and forms the outer periphery and major circumference of the device”)
Thus it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to implement the teachings of Linder-Ganz into Cengiz because by utilizing the above features from McCullen will result in accurate 3D modeling for 3D printing of the menisci of the patient.
Therefore it would have been obvious to one of ordinary skill to combine the two references to obtain the invention in Claim 7.
As per Claim 17, Claim 17 claims the same limitation as Claim 7 and is dependent on a similarly rejected independent claim. Therefore the rejection and rationale are analogous to that made in Claim 7.
Allowable Subject Matter
Claims 3-5, 8-10, 13-15 and 18-20 are 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MING HON whose telephone number is (571)270-5245. The examiner can normally be reached M-F 9am - 5pm.
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/MING Y HON/Primary Examiner, Art Unit 2666
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