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 .
Claim Objections
Claim 2 objected to because of the following informalities: (c-1) states “virtual cutting surfaces”, but (c-2) instead states “the cutting surfaces”. Appropriate correction is required.
Claim 9 objected to because of the following informalities: “the combined bone cross sections” are later referred to as only “the combined cross sections in the claim”. Appropriate correction is required.
Claim 10 objected to because of the following informalities: “the combined bone cross sections” are later referred to as only “the combined cross sections” in the claim. 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 1-13 rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea (mathematical calculations) without significantly more. The flow chart in MPEP 2106, Subject Matter Eligibility Test for Products and Processes, will be referred to establish ineligible subject matter.
Regarding claim 1, Step 1: the claims recites a method of reconstructing cartilage of a distal femur, which would be categorized as a process under the four recognized statutory categories. Step 2A Prong One: However, the claim is further directed to the abstract ideas (mathematical calculations) of obtaining a distance between an articular surface of the model (A) and a cartilage surface of the model (B) and obtaining a reconstruction line (L1) from the specific value generated from the obtained distance, which is a mathematical calculation (see MPEP 2106.04(a)(2)). Step 2A Prong Two: Additional elements include [1]. The addition of obtaining models and their cross sections for input and generating a reconstructed model based on the reconstruction line (L1) does not integrate the judicial exception into a practical application (see MPEP 2106.05(d)). Step 2B: The additional claim elements do not amount to significantly more than the judicial exception, as explained above. Therefore, the claim is ineligible.
Regarding claims 2-13, additional limitations do not amount to significantly more and therefore the claims are all ineligible.
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 2, 3, and 12 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.
Regarding claim 2, it recites “(c-2) extracting a bone cross section for each region through which each of the cutting surfaces passes in the model (A) and the model (B) by using the generated virtual cutting surfaces.”. The phrase “bone cross section for each region” lacks clear scope because claim 2 is dependent on claim 1 which also recites “using a bone cross section of the model (A) and a bone cross section of the model (B) which are extracted from the same region”. It is unclear whether the bone cross sections recited in claim 2 are the same as those recited in claim 1.
Regarding claim 3, it recites “The method of claim 2, wherein the region of interest comprises a distal medial condyle and a distal lateral condyle of the distal femur, and a posterior medial condyle and a posterior lateral condyle thereof.”. The phrase “the region of interest” lacks clear scope because claim 3 is dependent on claim 2 which also recites “within a preset region of interest”. It is unclear whether the region of interest recited in claim 3 is the same as the one recited in claim 2. For examination purposes, the region of interest of claim 3 will be viewed as “preset region of interest” in accordance to claim 2.
Regarding claim 12, it recites “The method of claim 6, wherein in the generating (e), the specific value for each section divided by the virtual cutting surfaces is used to form the reconstruction line (L1) for the each section”. The phrase “each section” lacks clear scope because claim 12 is dependent on claim 6 which is dependent on claim 2 which recites “(c-2) extracting a bone cross section for each region through which each of the cutting surfaces passes in the model (A) and the model (B) by using the generated virtual cutting surfaces.” It is unclear whether the each section recited in claim 12 is the same as “bone cross section for each region through which each of the cutting surfaces” in claim 2 or an entirely different section also related to the virtual cutting surfaces.
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.
Claims 1 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Park (US 20100042105 A1) in view of Bellettre (US 20100153081 A1).
Regarding claim 1, Park (US 20100042105 A1) discloses a method of reconstructing cartilage of a distal femur in which damaged cartilage of the distal femur is reconstructed to a pre-damaged state thereof for designing a patient-specific artificial knee joint (Park teaches “Disclosed herein are customized arthroplasty jigs 2 and systems 4 for, and methods of, producing such jigs 2. The jigs 2 are customized to fit specific bone surfaces of specific patients.” [0096]; "the thickness of cartilage can be analyzed in order to restore the damaged knee compartment back to its pre-OA status" [0193]), the method comprising:
(a) generating a distal femur model (A) having only a bone without cartilage from image data of a femur captured by a medical imaging device (Park teaches “FIG. 3A depicts 2D bone models or images 28', 28'' of the femur and tibia 18, 20 from medical imaging scans 16…[system] using a medical imaging process, such as magnetic resonance imaging (MRI), computed tomography (CT)” [0139-0140]; "The inner ellipse model 480' of the femoral condyle shows the femoral condyle surrounded by cortical bone without the cartilage attached" [0195]);
(b) generating a distal femur model (B) having damaged cartilage from the image data (Park teaches “FIG. 3A depicts 2D bone models or images 28', 28'' of the femur and tibia 18, 20 from medical imaging scans 16…[system] using a medical imaging process, such as magnetic resonance imaging (MRI), computed tomography (CT)” [0139-0140]; "the outer ellipse contour 480'' (i.e., the cartilage surface) of the other condyle (i.e., the damage or deteriorated condyle)" [0195]);
(c) extracting a bone cross section for each region in each of the model (A) and the model (B) (Park teaches"...measured based on the cartilage thickness tr between the inner ellipse 480' and outer ellipse 480''. MRI slices of the two condyles 302, 303 of the femur bone model 28' in areas A and B are taken to compare the respective ellipse contours in areas A and B." [0196]);
(d) obtaining a distance (d) between an articular surface of the model (A) and a cartilage surface of the model (B) at each predetermined point by using a bone cross section of the model (A) and a bone cross section of the model (B) which are extracted from the same region (Park teaches "The inner ellipse contour 480', representing the bone-only surface, and the outer ellipse contour 480'', representing the bone-and-cartilage surface, can be obtained. The minimum cartilage thickness tm.sub.min is measured based on the cartilage thickness tr between the inner ellipse 480' and outer ellipse 480''. MRI slices of the two condyles 302, 303 of the femur bone model 28' in areas A and B are taken to compare the respective ellipse contours in areas A and B." [0196]); and
(e) generating a distal femur model (C) with cartilage reconstructed (Park teaches “In one embodiment, the POP procedure is a manual process, wherein 2D bone images 28 (e.g., femur and tibia 2D images in the context of the joint being a knee) are manually analyzed to determine reference data to aid in the selection of a respective implant 34 and to determine the proper placement and orientation of saw cuts and drill holes that will allow the selected implant to restore the patient's joint to its natural, pre-deteriorated state.” [0112])
Park (US 20100042105 A1) fails to disclose or teach where Bellettre (US 20100153081 A1) discloses (e) generating a distal femur model (C) with cartilage reconstructed according to a reconstruction line (L1) offset by a thickness of the cartilage from the articular surface of the model (A) after presetting a specific value of the distance (d) obtained in the obtaining (d) as the thickness of the cartilage to be reconstructed (Bellettre teaches "an exemplary process (450) for estimating areas representing cartilage. The surface of the cartilage is estimated at selected points by taking one cartilage measurement at locations on the patient's cartilage that correspond to each control point and using the resulting distance and direction from the representation of the bone to create an area representing cartilage using the representation of the bone and the resulting offset [reconstruction line]." [0091]; the resulting cartilage calculation is later referred to as "cartilage thickness" [0097])
Therefore, it would have been obvious to a person of ordinary skill in the art prior to the
effective filing date of the claimed invention to have modified Park (US 20100042105 A1) to incorporate the teachings of Bellettre (US 20100153081 A1) to generate a distal femur model with reconstructed cartilage using the obtained distance in order to enable accurate implant placement, improve joint performance, provide consistent and predictable results, achieving a fit that addresses patient unique anatomy (See Bellettre (US 20100153081 A1) [0007]).
Regarding claim 13, the combination of Park (US 20100042105 A1) and Bellettre (US 20100153081 A1) discloses a non-transitory recording medium storing a program programmed to execute a step-by-step process according to the method of reconstructing a distal femur according to claim 1 in a computer step by step (Bellettre teaches "The implementation can be as a computer program product (i.e., a computer program tangibly embodied in an information carrier). The implementation can, for example, be in a machine-readable storage device, for execution by, or to control the operation of, a data processing apparatus." [0195]).
Claims 2, 3, 4, 6, 8, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Park (US 20100042105 A1) in view of Bellettre (US 20100153081 A1) as applied to claim 1 and in further view of Lang (US 20070015995 A1).
Regarding claim 2, the combination of Park (US 20100042105 A1) and Bellettre (US 20100153081 A1) discloses The method of claim 1, wherein the extracting (c) comprises:
(c-1) generating several virtual cutting surfaces Park teaches "image slices may extend medial-lateral in planes [cutting surfaces]...series of 2D axial femur slices...find the most posterior point of each condyle....series of 2d coronal femur slices...find the most distal point of each condyle" [0151-0154]), and
(c-2) extracting a bone cross section for each region through which each of the cutting surfaces passes in the model (A) and the model (B) by using the generated virtual cutting surfaces (Park teaches "image slices may extend medial-lateral in planes [cutting surfaces]...series of 2D axial femur slices...find the most posterior point of each condyle....series of 2d coronal femur slices...find the most distal point of each condyle" [0151-0154]; Examiner notes, distal and posterior are the regions in this art;"...measured based on the cartilage thickness tr between the inner ellipse 480' and outer ellipse 480''. MRI slices of the two condyles 302, 303 of the femur bone model 28' in areas A and B are taken to compare the respective ellipse contours in areas A and B." [0196]).
The combination of Park (US 20100042105 A1) and Bellettre (US 20100153081 A1) fails to disclose or teach where Lang (US 20070015995 A1) discloses (c-1) generating several virtual cutting surfaces relative to a specific rotational axis of a distal femur in each of the model (A) and the model (B) within a preset region of interest (Lang teaches "One can begin with the trans-epicondylar reference...then generate a plane coincident with this line oriented in an arbitrary initial position. The intersection of this plane and the external surface of the cartilage will produce a curve...rotate the plane by some increment, for example by one degree, and repeat the procedure....This can be repeated for the entire extent of the cartilage" [0414-0415])
Therefore, it would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the combination of Park (US 20100042105 A1) and Bellettre (US 20100153081 A1) to incorporate the teachings of Lang (US 20070015995 A1) to generate several virtual cutting surfaces relative to a specific rotational axis of the distal femur models within a preset region of interest in order to “calculate a ‘natural’ line of curvature for each femoral cartilage component” (See Lang (US 20070015995 A1) [0414]).
Regarding claim 3, the combination of Park (US 20100042105 A1), Bellettre (US 20100153081 A1), and Lang (US 20070015995 A1) discloses the method of claim 2, wherein the region of interest (Park teaches “series of 2D axial femur slices...find the most posterior point of each condyle....series of 2d coronal femur slices...find the most distal point of each condyle" [0151-0154]) comprises a distal medial condyle and a distal lateral condyle of the distal femur, and a posterior medial condyle and a posterior lateral condyle thereof (Bellettre teaches ''bone points along a femur 500 for implant planning" [100]; "F3--Most distal medial point; F4--Most distal lateral point; F5--Most posterior medial point; F6--Most posterior lateral point;" [104-106]).
Regarding claim 4, the combination of Park (US 20100042105 A1), Bellettre (US 20100153081 A1), and Lang (US 20070015995 A1) discloses the method of claim 2, wherein the specific rotational axis is a transepicondylar axis of the distal femur or a flexion-extension axis of the distal femur (Lang teaches "One can begin with the trans-epicondylar reference line previously described. One can then generate a plane coincident with this line oriented in an arbitrary initial position." [0414]).
Regarding claim 6, the combination of Park (US 20100042105 A1), Bellettre (US 20100153081 A1) and Lang (US 20070015995 A1) discloses the method of claim 2, wherein the obtaining (d) comprises:
(d-1) generating combined bone cross sections by combining bone cross sections which are extracted from the same regions among a plurality of bone cross sections extracted from each of the model (A) and the model (B) (Lang teaches "The femoral, tibial, and patellar cartilage can be segmented separately...the contours of the femoral, tibial, and patellar bone can be segmented separately...Fat-saturated and non-fat-saturated 3D sequences can be acquired with the same field of view, slice thickness and slice positions, thereby enabling superimposition and cross registration of any resultant 3D renderings of the femoral, tibial, and patellar cartilage and bone" [0235]), and
(d-2) obtaining the distance between the articular surface of the model (A) and the cartilage surface of the model (B) at each predetermined point (Park teaches "The inner ellipse contour 480', representing the bone-only surface, and the outer ellipse contour 480'', representing the bone-and-cartilage surface, can be obtained. The minimum cartilage thickness tm.sub.min is measured based on the cartilage thickness tr between the inner ellipse 480' and outer ellipse 480''. MRI slices of the two condyles 302, 303 of the femur bone model 28' in areas A and B are taken to compare the respective ellipse contours in areas A and B." [0196]) in each of the combined bone cross sections (Lang teaches “…thereby enabling superimposition and cross registration of any resultant 3D renderings of the femoral, tibial, and patellar cartilage and bone" [0235]).
Regarding claim 8, the combination of Park (US 20100042105 A1), Bellettre (US 20100153081 A1), and Lang (US 20070015995 A1) discloses the method of claim 6, wherein in the generating (e), one of a maximum among distance values calculated from each point, a mode which occurs most frequently among distance values calculated from each point, a median among distance values calculated from each point, and an average of distance values calculated from each point is used as the specific value (Lang teaches "The invention provides for means for calculating the area covered by the cartilage defect A.sub.cartilage defect and the mean thickness of the cartilage in the region of the defect D.sub.cartilage defect as well as the mean thickness of a defined area of surrounding normal cartilage. The thickness of the cartilage previously lost in the defect can be estimated then as: D.sub.cartilage loss=D.sub.normal cartilage-D.sub.cartilage defect" [0252]).
Regarding claim 12, the combination of Park (US 20100042105 A1), Bellettre (US 20100153081 A1), and Lang (US 20070015995 A1) discloses the method of claim 6, wherein in the generating (e), the specific value for each section divided by the virtual cutting surfaces is used to form the reconstruction line (L1) for the each section (Lang teaches "the cartilage is segmented slice by slice from MR images...each slice that contains the defect...the distances...between the OCS [outer cartilage surface]….and the ICS [inner cartilage surface] can be measured. For OCS reconstruction the OCS-ICS distance can be determined...distance values can be used to determine a set of...surface points for the reconstructed OCS...The surface contour...can be determined with a spline curve that interpolates this set of OCS points" [0255]).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Park (US 20100042105 A1) in view of Bellettre (US 20100153081 A1) and Lang (US 20070015995 A1) as applied to claim 2 and in further view of Metzger (US 20070288030 A1).
Regarding claim 5, the combination of Park (US 20100042105 A1), Bellettre (US 20100153081 A1), and Lang (US 20070015995 A1) fails to disclose or teach where Metzger (US 20070288030 A1) discloses wherein the specific rotational axis is an axis passing through a medial sagittal radius center or a lateral sagittal radius center of the distal femur in a width direction of the distal femur (Metzger teaches "After the scan data is converted to three dimensional images of the patient anatomy from hip to ankle, images of the tibial and femoral components can be manipulated for obtaining patient-specific alignment by making use of the femoral and tibial mechanical axes 402, 404, illustrated in FIG. 3, and the transepicondylar and cylindrical axes 406, 408, illustrated in FIG. 4. Images of the knee joint anatomy can include images of the joint surfaces of the distal femur and proximal tibial with or without the associated soft tissues, such as articular cartilage, on the respective bone surfaces...The cylindrical axis is the line connecting the centers of the condyles when the condyles are approximated by coaxial cylinders" [0041-0042] see Fig. 3 and 4)
Therefore, it would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the combination of Park (US 20100042105 A1), Bellettre (US 20100153081 A1), and Lang (US 20070015995 A1) to incorporate the teachings of Metzger (US 20070288030 A1) to set it so that the specific rotational axis is one that passes through a medial sagittal radius center or lateral sagittal radius center of the distal femur in a width direction of the distal femur in order to obtain patient specific alignment (See Metzger (US 20070288030 A1) [0041]).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Park (US 20100042105 A1) in view of Bellettre (US 20100153081 A1) and Lang (US 20070015995 A1) as applied to claim 6 and in further view of Yao (US 20230222651 A1).
Regarding claim 7, the combination of Park (US 20100042105 A1), Bellettre (US 20100153081 A1), and Lang (US 20070015995 A1) fails to disclose or teach where Yao (US 20230222651 A1) discloses wherein in the obtaining (d-2), the distance between the articular surface and the cartilage surface at the predetermined point is obtained in a normal direction of the articular surface (Yao teaches "Articular cartilage has an “inner” surface (at the bone-cartilage interface) and an “outer” surface opposite the inner surface...surface normal can be computed for some or all of the vertices of the reference surface. A thickness map can be generated by determining respective distances from different vertices on the reference the surface to corresponding points on the outer surface, e.g., along a surface normal from the vertex on the reference surface." [0043]).
Therefore, it would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the combination of Park (US 20100042105 A1), Bellettre (US 20100153081 A1), and Lang (US 20070015995 A1) to incorporate the teachings of Yao (US 20230222651 A1) to obtain the distance in a normal direction as it is a preferred choice for clinical applications because the bone-cartilage interface is less likely to change over time (See Yao (US 20230222651 A1) [0043]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Park (US 20100042105 A1) in view of Bellettre (US 20100153081 A1) and Lang (US 20070015995 A1) as applied to claim 6 and in further view of Ajrapetov (RU 2681923 C1).
Regarding claim 9, the combination of Park (US 20100042105 A1), Bellettre (US 20100153081 A1), and Lang (US 20070015995 A1) fails to disclose or teach where Ajrapetov (RU 2681923 C1) discloses wherein in the generating (e), for each of the combined bone cross sections, the distance between the articular surface of the model (A) and the cartilage surface of the model (B) is calculated at each predetermined point to obtain averages of the distances for the combined cross sections, and a maximum of the obtained averages of the distances for the combined cross sections is used as the specific value (Ajrapetov teaches "The thickness of the cartilage of both articular surfaces along the perimeter with a step of 2 mm is noted...the average thickness of the hyaline cartilage in each area is determined" and uses "the maximum value of the average thickness of the cartilage" [3/13]).
Therefore, it would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the combination of Park (US 20100042105 A1), Bellettre (US 20100153081 A1), and Lang (US 20070015995 A1) to incorporate the teachings of Ajrapetov (RU 2681923 C1) to obtain averages of distances for the combined cross sections, and a maximum of the obtained averages of the distances for the combined cross sections is used as the specific value in order to more reliably assess the condition of the cartilage and prescribe the appropriate treatment (See Ajrapetov (RU 2681923 C1) [4/12]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Park (US 20100042105 A1) in view of Bellettre (US 20100153081 A1) and Lang (US 20070015995 A1) as applied to claim 6 and in further view of Kerwin (US 20100312090 A1).
Regarding claim 10, the combination of Park (US 20100042105 A1), Bellettre (US 20100153081 A1), and Lang (US 20070015995 A1) discloses combined bone cross sections (Lang teaches “…thereby enabling superimposition and cross registration of any resultant 3D renderings of the femoral, tibial, and patellar cartilage and bone" [0235]), but fails to disclose or teach where Kerwin (US 20100312090 A1) discloses wherein in the generating (e), for each of the bone cross sections, the distance between the articular surface of the model (A) and the cartilage surface of the model (B) is calculated at each predetermined point to extract maximums of the distances for the cross sections, and an average of the extracted maximums for the cross sections is used as the specific value (Kerwin teaches "maximum length of the lines of thickness, d.sub.i.sup.max, for each cross-sectional image within the longitudinal segment affected by the selected plaque component...In a step 102, these maximum values are then averaged, and the average is set equal to the maximum thickness" [0047]).
Therefore, it would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the combination of Park (US 20100042105 A1), Bellettre (US 20100153081 A1), and Lang (US 20070015995 A1) to incorporate the teachings of Kerwin (US 20100312090 A1) to extract maximums of the distances for the combined cross sections, and an average of the extracted maximums for the combined cross sections is used as the specific value in order to “limit the impact of isolated measurement errors due to misplacement of vessel boundaries” (See Kerwin (US 20100312090 A1) [0047]).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Park (US 20100042105 A1) in view of Bellettre (US 20100153081 A1) and Lang (US 20070015995 A1) as applied to claim 6 and in further view of Wong (US 20120041446 A1).
Regarding claim 11, the combination of Park (US 20100042105 A1), Bellettre (US 20100153081 A1), and Lang (US 20070015995 A1) fails to disclose or teach where Wong (US 20120041446 A1) discloses the method of claim 6, wherein in the generating (e), the specific value is applied to an entirety of the articular surface S1 of the model (A) belonging to the region of interest (ROI) to form the reconstruction line (L1) (Wong teaches "cartilage surface information may be estimated by offsetting the underlying bone surface by the expected cartilage thickness" [0197]; "standard cartilage thickness may....be uniform across one or more articular surfaces" [0354]; “The disclosed procedure also provides a repeatable and easily identifiable method of identifying a region of interest and quickly and easily constructing an appropriate anatomical relief structure to accommodate some or all of the region.” [0612]; "cartilage surface information may be estimated by offsetting the underlying bone surface by the expected cartilage thickness" [0661]).
Therefore, it would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the combination of Park (US 20100042105 A1), Bellettre (US 20100153081 A1), and Lang (US 20070015995 A1) to incorporate the teachings of Wong (US 20120041446 A1) to apply the specific value to the entirety of the articular surface to form a reconstruction line in order to “facilitate the imaging protocols required for pre-operative planning” (See Wong (US 20120041446 A1) [0197]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMMAD A KHAN whose telephone number is (571)272-0283. The examiner can normally be reached Monday - Thursday, 7 a.m. 6 p.m. ET..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vincent Rudolph can be reached at (571) 272-8243. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M. Ali Khan/ Examiner, Art Unit 2671
/VINCENT RUDOLPH/ Supervisory Patent Examiner, Art Unit 2671
