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 .
Application Status
Present office action is in response to amendment filed 04/20/2026. Claims 1-21 are currently pending in the application.
Rejections - 35 USC § 102/103
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 (i.e., changing from AIA to pre-AIA ) 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 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.
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) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claims 1-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by PERLER et al. (US 20210077192 A1) (PERLER) cited by Applicant or, in the alternative, under 35 U.S.C. 103 as obvious over PERLER in view of Mahfouz (US 20160157751 A1).
Re claims 1-21:
[Claim 1] PERLER discloses a method for providing a three-dimensional (3D) physical model for a surgical procedure (at least ¶ 3: Cutting guides are often used to help the surgeon properly locate the cut; ¶¶ 5-11, 13: a method may be used to correct a condition present in a patient … obtaining a first bone model of a first bone of one or more bones of the patient's foot, and using at least the first bone model to generate a cutting guide model … obtaining a second bone model of the metatarsus; ¶ 16: using at least the first bone model to generate an implant model defining a first bone-facing surface with a first shape that matches a first profile of a first resected surface of the first bone after resection of the first bone with a cutting guide fabricated using the cutting guide mode; ; ¶ 44: a three-dimensional model of the patient's anatomy, or three-dimensional surface points that can be used to construct such a three-dimensional model), the method comprising: accessing a computer model of deformed osseous anatomy of a patient based on medical imaging data of the deformed osseous anatomy (at least ¶ 8: obtaining a second bone model of the metatarsus, and virtually repositioning the second bone model relative to the first bone model to simulate reorientation of the metatarsus relative to the cuneiform to correct the bunion; ¶ 13: Using the first bone model to generate the cutting guide model; ¶ 16: using at least the first bone model to generate an implant model defining a first bone-facing surface with a first shape that matches a first profile of a first resected surface of the first bone after resection of the first bone with a cutting guide fabricated using the cutting guide model; ¶ 18: using the implant model to fabricate an implant having the first bone-facing surface and the second bone-facing surface; ¶ 27: FIG. 1B is a flowchart diagram depicting a method for correcting bunion deformity u of the human foot; ¶ 28: FIG. 2 is a perspective view of a portion of a foot with a bunion deformity to be treated through use of the methods of FIGS. 1A and/or 1B; ¶ 37: FIG. 10 is a rear, perspective view of the foot of FIG. 2, after performance of an Evans calcaneal osteotomy and a medializing calcaneal osteotomy with patient-specific instruments and/or implants; ¶ 38: FIG. 11 is a perspective view of the implant of FIG. 10, in isolation;); fabricating a tangible, physical 3D bone model of the deformed osseous anatomy based on the computer model, wherein the tangible, physical 3D bone model physically represents the deformed osseous anatomy of the patient; and providing the tangible, physical 3D bone model to a surgeon (at least ¶ 44: … possession of a three-dimensional model of the patient's anatomy, or three-dimensional surface points that can be used to construct such a three-dimensional model; ¶ 47: the model(s) may be used to manufacture patient-specific instrumentation and/or implants. This may be done via any known manufacturing method, including casting, forging, milling, additive manufacturing, and/or the like …; ¶ 48: the model(s) may be used to select from available sizes of implants and/or instruments and advise the surgeon accordingly; ¶ 49: the result of the step 108 may be provision, to the surgeon, of one or more of the following: (1) one or more patient-specific instruments; (2) one or more patient-specific implants; (3) an instrument, selected from one or more available instrument sizes and/or configurations; (4) an implant, selected from one or more available implant sizes and/or configurations; (5) instructions for which instrument(s) to select from available instrument sizes and/or configurations; (6) instructions for which implant(s) to select from available implant sizes and/or configurations; (7) instructions for proper positioning or anchorage of one or more instruments to be used in the procedure; and (8) instructions for proper positioning or anchorage of one or more implants to be used in the procedure. These items may be provided to the surgeon directly, or to a medical device company or representative, for subsequent delivery to the surgeon; ¶ 50: the manufactured instrumentation may be used in surgery to facilitate treatment of the condition. In some embodiments, this may entail placing the modelled bone apposition surface against the corresponding contour of the bone used to obtain its shape, and then using the guide feature(s) to guide resection of one or more bones. Then the bone(s) may be further treated, for example, by attaching one or more joint replacement implants (in the case of joint arthroplasty), or by attaching bone segments together (in the case of arthrodesis or fracture repair); ¶ 53: the method 120 may begin with a step 122 in which a CT scan (or another three-dimensional image) of the patient's foot is obtained … ; ¶ 56: the model(s) may be used to manufacture patient-specific instrumentation and/or instruments. This may include manufacturing the cutting guide with the bone apposition surface and the guide features as described above. As in the step 108, the step 128 may additionally or alternatively involve provision of one or more instruments and/or implants from among a plurality of predetermined configurations or sizes. Further, the step 128 may additionally or alternatively involve provision of instructions for placement and/or anchorage of one or more instruments and/or instruments to carry out the procedure; ¶ 94: a wide variety of patient-specific instruments may be used in connection with the method 100, including but not limited to cutting guides, gages, implant positioning guides, joint distractors, joint compressors, soft tissue retractors, and the like; ¶ 103: …The implant 1060 may be fabricated specifically for the patient, since the precise angulation and position of the realignment may also be patient specific … ; ¶ 107: Patient-specific cutting guides may be designed, fabricated, and surgically used to facilitate any of these procedures through the presence of bone engagement surfaces that are shaped to rest on the particular bony surfaces adjacent to the osteotomy; ¶ 111: the bone plate 1070 may also be fabricated specifically for the foot 200, enabling the bone plate 1070 to maintain precisely the desired level of correction. When made specifically for the foot 200 in combination with each other, the implant 1060 and the bone plate 1070 may provide a highly predictable, precise, and customizable level of correction of the flat foot deformity).
Alternatively, in the event the above interpretation of PERLER in regard to fabricating a tangible, physical 3D bone model of the deformed osseous anatomy based on the computer model, wherein the tangible, physical 3D bone model physically represents the deformed osseous anatomy of the patient; and providing the tangible, physical 3D bone model to a surgeon is viewed as not being reasonable, Mahfouz teaches or at least suggests fabricating a tangible, physical 3D bone model (at least ¶ 206: FIGS. 1-8, reconstruction of a deformed anatomy or a partial anatomy is one of the complex problems facing healthcare providers. Loss of anatomy may be the result of birth conditions, tumors, diseases, personal injuries, or failure of previous surgeries. As part of providing treatment for various ailments, healthcare providers may find it advantageous to reconstruct an anatomy or construct an anatomy to facilitate treatment for various conditions that may include, without limitation, broken/shattered bones, bone degeneration, orthopedic implant revision, joint degeneration, and custom instrumentation design; ¶ 207: FIGS. 1-8, reconstruction of a deformed anatomy or a partial anatomy is one of the complex problems facing healthcare providers. Loss of anatomy may be the result of birth conditions, tumors, diseases, personal injuries, or failure of previous surgeries. As part of providing treatment for various ailments, healthcare providers may find it advantageous to reconstruct an anatomy or construct an anatomy to facilitate treatment for various conditions that may include, without limitation, broken/shattered bones, bone degeneration, orthopedic implant revision, joint degeneration, and custom instrumentation design; ¶ 212: This 3D model is a full, normal reconstruction of the bone(s) in question …; ¶ 244: Regardless of the context, whether partial, deformed, and/or shattered anatomies of the patient are at issue, the exemplary system and process for generating patient-specific implants and/or guides utilizes the foregoing exemplary process and system of 3D bone model reconstruction (see FIGS. 1-7 and the foregoing exemplary discussion of the same) to generate a three dimensional model of the patient's reconstructed anatomy; ¶ 424: The input anatomy data is utilized to construct a three dimensional virtual model of the fractured anatomy …; ¶ 430: As part of providing treatment for various ailments, healthcare providers may find it advantageous to reconstruct an anatomy or construct an anatomy to facilitate treatment for various conditions that may include, without limitation, broken/shattered bones, bone degeneration, orthopedic implant revision, orthopedic initial implantation, and disease; ¶ 442: The bone model of the patient's hip is also utilized to generate a tangible, 3D bone model. In exemplary form, the software is programmed to output the virtual 3D bone model as machine code, thereby allowing rapid prototyping of the tangible 3D bone model, either in an additive or subtractive process … an additive process includes 3D printing where the model is created from a starting blank canvas by the addition of material to form discrete layers or slices of the bone model that, once stacked upon one another by printing successive layers, form the final bone model … a subtractive process includes starting with a solid block of material and, using machine code (e.g., CNC code) to machine away material to arrive at a solid bone model. Those skilled in the art will understand that any number of processes may be utilized to fabricate a tangible bone model; ¶ 447: generate virtual 3D guides that may be utilized to output machine code sufficient to construct a tangible 3D placement guide for the revision cage; ¶ 448: The bone model of the patient's hip is also utilized to generate a tangible, 3D bone model … the software is programmed to output the virtual 3D bone model as machine code, thereby allowing rapid prototyping of the tangible 3D bone model, either in an additive or subtractive process …). Hence, it would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the invention to have used the patient-specific and customized orthopedic implants features of Mahfouz to modify PERLER as claimed because this would amount to no more than applying known techniques to a known device (method, or product) ready for improvement to yield predictable results. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (“The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.”).
[Claim 2-10] PERLER in view of Mahfouz teaches or at least suggests wherein the deformed osseous anatomy comprises a plurality of bones of the patient and wherein fabricating the tangible, physical 3D bone model comprises coupling two physical bone models of the tangible, physical 3D bone model by way of an interconnect such that the two physical bone models connect in correspondence with patient bones of the deformed osseous anatomy, [(Claim 3)] wherein the interconnect comprises an interface configured to enable a user to reposition one physical bone model in relation to another physical bone model coupled to the interface, [(Claim 4)] wherein the interconnect comprises a rigid interconnect, [(Claim 5)] wherein the interconnect comprises a detachable interconnect, [(Claim 6)] wherein fabricating the tangible, physical 3D bone model comprises coupling a plurality of physical bone models of the tangible, physical 3D bone model by way of a plurality of interconnects and wherein the plurality of interconnects comprises rigid interconnects and adjustable interconnects (at least PERLER: ¶ 7: The first guide feature may be positioned to guide resection of the cuneiform. The cutting guide model may further define a second bone engagement surface shaped to match a second contour of the metatarsus, and a second guide feature that, with the second bone engagement surface overlying the second contour, is positioned to guide resection of the metatarsus; ¶ 8: obtaining a second bone model of the metatarsus, and virtually repositioning the second bone model relative to the first bone model to simulate reorientation of the metatarsus relative to the cuneiform to correct the bunion; FIGS. 3A through 3D and associated text; FIG 10 and associated text; ¶ 40: … interaction between two or more entities, including mechanical, electrical, magnetic, electromagnetic, fluid, and thermal interaction …), [(Claim 7)] wherein fabricating the tangible, physical 3D bone model comprises providing an indicator on a physical bone model of the tangible, physical 3D bone model, the indicator configured to convey information about at least one of the osseous anatomy, the patient, and the surgical procedure, [(Claim 8)] wherein the indicator identifies a physical bone model corresponding to a patient bone having a deformed bone condition (at least ¶¶ 73, 74: FIGS. 3A through 3D, the body 310 may further have features that facilitate proper positioning of the cutting guide 300 on the first cuneiform 210 and the first metatarsus 230. More specifically, the body 310 may have a first bone indicator 360 with the text “CUN,” indicating that the end of the body 310 with the first bone indicator 360 is to be positioned over the first cuneiform 210. Similarly, the body 310 may have a second bone indicator 362 with the text “MET,” indicating that the end of the body 310 with the second bone indicator 362 is to be positioned over the first metatarsus 230. In addition, the body 310 may have a side indicator 370 with the text “LEFT,” indicating that the cutting guide 300 is to be used in connection with the patient's left foot. The side indicator 370 may be particularly helpful when bunion corrections are to be provided on both of the patient's feet. In such a case, the surgeon may manufacture or receive two separate cutting guides: one for the left foot (the foot 200 of FIG. 2) and another for the right foot (not shown) …), [(Claim 9)] comprising fabricating a 3D physical instrument of a patient-specific instrument configured for use on the deformed osseous anatomy of the patient for the surgical procedure, [(Claim 10)] wherein the 3D physical instrument comprises a bone engagement member configured to engage a bone of the deformed osseous anatomy and to engage a physical bone model of the tangible, physical 3D bone model corresponding to the bone of the deformed osseous anatomy (at least ¶¶ 76-78: pins 500 may be inserted through the holes 340 in the body 310 and anchored in the first cuneiform 210 and the first metatarsus 230. Each of the pins 500 may have a sharp and/or threaded distal end that can penetrate and/or readily be retained in the bone of the first cuneiform 210 or the first metatarsus 230. Additionally or alternatively, a drill or other hole-forming instrument may be used to pre-form holes in the first cuneiform 210 and/or the first metatarsus 230 to receive the distal ends of the pins 50 …).
[Claims 11-15] PERLER discloses a method for providing a three-dimensional (3D) physical model for a surgical procedure (at least ¶ 5: a method may be used to correct a condition present in a patient; ¶ 44: a three-dimensional model of the patient's anatomy, or three-dimensional surface points that can be used to construct such a three-dimensional model), the method comprising: generating a computer model of osseous anatomy of a patient based on medical imaging data of the osseous anatomy (at least ¶ 8: obtaining a second bone model of the metatarsus, and virtually repositioning the second bone model relative to the first bone model to simulate reorientation of the metatarsus relative to the cuneiform to correct the bunion; ¶ 13: Using the first bone model to generate the cutting guide model may include converting the CT scan data to a CAD models, using the CAD model to obtain the first contour, and using the first contour to generate the first bone engagement surface of the cutting guide mode; ¶ 44: the method 100 may begin with a step 102 in which a CT scan (or another three-dimensional image) of the patient's anatomy is obtained. The step 102 may entail capturing a scan of only the particular bone(s) to be treated, or may entail capture of additional anatomic information, such as the surrounding tissues. Additionally or alternatively, the step 102 may entail receiving a previously captured image, for example, at a design and/or fabrication facility. Performance of the step 102 may result in possession of a three-dimensional model of the patient's anatomy, or three-dimensional surface points that can be used to construct such a three-dimensional model; ¶ 53: the method 120 may begin with a step 122 in which a CT scan (or another three-dimensional image) of the patient's foot is obtained. … ¶ 55: In a step 126, the CAD model and/or CT scan data may be used to model patient-specific instrumentation that can be used to correct the bunion deformity. Such instrumentation may include a cutting guide that is attachable to the first cuneiform and the first metatarsus, with two guide features that facilitate resection of the cuneiform and the metatarsus in preparation for arthrodesis. In some embodiments, performance of the step 126 may include modelling the cutting guide with a bone apposition surface that is shaped to match contours of the surfaces of the cuneiform and the metatarsus, such that the bone apposition surface can lie directly on the corresponding contours of the first cuneiform and the first metatarsus; ¶ 101: The cut between the first bone segment 1040 and the second bone segment 1042 may be carried out virtually (for example, in CAD) on a model of the calcaneus 1000 obtained from a CT scan or other imaging of the patient's foot); generating a modified computer model of the osseous anatomy, the modified computer model altered from the computer model of the osseous anatomy such that the modified computer model represents the osseous anatomy after a surgical procedure (at least ¶¶ 44, 55: … the step 102 may entail receiving a previously captured image, for example, at a design and/or fabrication facility. Performance of the step 102 may result in possession of a three-dimensional model of the patient's anatomy, or three-dimensional surface points that can be used to construct such a three-dimensional mode; the CAD model and/or CT scan data may be used to model patient-specific instrumentation that can be used to correct the bunion deformity. Such instrumentation may include a cutting guide that is attachable to the first cuneiform and the first metatarsus, with two guide features that facilitate resection of the cuneiform and the metatarsus in preparation for arthrodesis. In some embodiments, performance of the step 126 may include modelling the cutting guide with a bone apposition surface that is shaped to match contours of the surfaces of the cuneiform and the metatarsus, such that the bone apposition surface can lie directly on the corresponding contours of the first cuneiform and the first metatarsus; ¶ 63: the degree of angular adjustment needed in each direction may be different for every patient. Use of a patient-specific cutting guide may help the surgeon obtain the optimal realignment in the lateral direction 260 and in the plantar direction 280 or the dorsal direction 290; ¶ 84: shaping may be accomplished by custom-designing the implant 610 for the patient, using the same models (for example, from CT scans) of the first metatarsus 230 and the first cuneiform 210 that were used to generate the cutting guide 300. Thus, the implant 610 may have a shape that provides secure attachment and/or fusion between the first metatarsus 230 and the first cuneiform 210 while avoiding proud edges or other protruding features that could otherwise interfere with surrounding tissues; ¶ 89: The bone apposition side 730 may be custom contoured to match the shapes of the first cuneiform 210 and/or the first metatarsus 230; ¶ 105: If desired, the model of the calcaneus 1000 may be divided and manipulated in CAD to simulate the repositioning of the heel 1050 pursuant to the medializing calcaneal osteotomy; ¶ 108: As in the case of the Evans calcaneal osteotomy, a custom cutting guide, or cutting guide 1053, may be generated to help the surgeon obtain the correction that was previously modeled and/or planned using the computer models of the foot 200); fabricating a preoperative 3D physical bone model of the osseous anatomy based on the computer model of the osseous anatomy before the surgical procedure (at least ¶ 48: where a range of cutting guides are available for a given procedure, analysis of the CAD data may facilitate pre-operative selection of the optimal cutting guide and/or optimal placement of the cutting guide on the bone. Similarly, if a range of implants may be used for a given procedure, analysis of the CAD data may facilitate pre-operative selection of the optimal implant(s); ¶¶ 51, 52, 53, 54, 55, 56, 57, 60-64, 69; ¶ 107: Patient-specific cutting guides may be designed, fabricated, and surgically used to facilitate any of these procedures through the presence of bone engagement surfaces that are shaped to rest on the particular bony surfaces adjacent to the osteotomy; ¶ 111: the bone plate 1070 may also be fabricated specifically for the foot 200, enabling the bone plate 1070 to maintain precisely the desired level of correction. When made specifically for the foot 200 in combination with each other, the implant 1060 and the bone plate 1070 may provide a highly predictable, precise, and customizable level of correction of the flat foot deformity); fabricating a preoperative 3D physical bone model comprising a tangible, physical representation of one or more bones of the osseous anatomy of the patient based on the computer model of the osseous anatomy before the surgical procedure; providing preoperative 3D physical bone model to a user (at least ¶ 10: using the cutting guide model to fabricate a cutting guide having the first bone engagement surface, the second bone engagement surface, the first bone attachment feature, the second bone attachment feature, the first guide feature, and the second guide feature; ¶ 16: using at least the first bone model to generate an implant model defining a first bone-facing surface with a first shape that matches a first profile of a first resected surface of the first bone after resection of the first bone with a cutting guide fabricated using the cutting guide model; ¶ 18; ¶ 35: FIGS. 8A, 8B, and 8C are dorsal pre-operative, dorsal post-operative, and lateral post-operative views, respectively, of a foot …; ¶ 36: FIGS. 9A and 9B are dorsal post-operative and lateral post-operative views, respectively, of a foot treated …; ¶ 44: Performance of the step 102 may result in possession of a three-dimensional model of the patient's anatomy, or three-dimensional surface points that can be used to construct such a three-dimensional model; ¶ 98: FIGS. 8A, 8B, and 8C are dorsal pre-operative, dorsal post-operative, and lateral post-operative views, respectively, of a foot treated with an Evans calcaneal osteotomy; ¶ 99: FIGS. 9A and 9B are dorsal post-operative and lateral post-operative views, respectively, of a foot treated with a medializing calcaneal osteotomy, according to one embodiment. A medializing calcaneal osteotomy (heel slide) procedure is often used when the calcaneus (heel bone) has shifted out from underneath the leg; ¶ 100: FIG. 10 is a rear, perspective view of the foot 200 of FIG. 2, after performance of an Evans calcaneal osteotomy and a medializing calcaneal osteotomy with patient-specific instruments and/or implants; ¶ 101: The cut between the first bone segment 1040 and the second bone segment 1042 may be carried out virtually (for example, in CAD) on a model of the calcaneus 1000 obtained from a CT scan or other imaging of the patient's foot. Thus, the optimal realignment of the posterior end of the calcaneus 1000 can be obtained. If desired, a patient-specific cutting guide, or cutting guide 1043, may be generated in order to facilitate resection of the calcaneus 1000).
Alternatively, in the event the above interpretation of PERLER in regard to fabricating a preoperative 3D physical bone model comprising a tangible, physical representation of one or more bones of the osseous anatomy of the patient based on the computer model of the osseous anatomy before the surgical procedure is viewed as not being reasonable, Mahfouz teaches or at least suggests fabricating a tangible, physical 3D bone model (at least ¶ 206: FIGS. 1-8, reconstruction of a deformed anatomy or a partial anatomy is one of the complex problems facing healthcare providers. Loss of anatomy may be the result of birth conditions, tumors, diseases, personal injuries, or failure of previous surgeries. As part of providing treatment for various ailments, healthcare providers may find it advantageous to reconstruct an anatomy or construct an anatomy to facilitate treatment for various conditions that may include, without limitation, broken/shattered bones, bone degeneration, orthopedic implant revision, joint degeneration, and custom instrumentation design; ¶ 207: FIGS. 1-8, reconstruction of a deformed anatomy or a partial anatomy is one of the complex problems facing healthcare providers. Loss of anatomy may be the result of birth conditions, tumors, diseases, personal injuries, or failure of previous surgeries. As part of providing treatment for various ailments, healthcare providers may find it advantageous to reconstruct an anatomy or construct an anatomy to facilitate treatment for various conditions that may include, without limitation, broken/shattered bones, bone degeneration, orthopedic implant revision, joint degeneration, and custom instrumentation design; ¶ 212: This 3D model is a full, normal reconstruction of the bone(s) in question …; ¶ 244: Regardless of the context, whether partial, deformed, and/or shattered anatomies of the patient are at issue, the exemplary system and process for generating patient-specific implants and/or guides utilizes the foregoing exemplary process and system of 3D bone model reconstruction (see FIGS. 1-7 and the foregoing exemplary discussion of the same) to generate a three dimensional model of the patient's reconstructed anatomy; ¶ 424: The input anatomy data is utilized to construct a three dimensional virtual model of the fractured anatomy …; ¶ 430: As part of providing treatment for various ailments, healthcare providers may find it advantageous to reconstruct an anatomy or construct an anatomy to facilitate treatment for various conditions that may include, without limitation, broken/shattered bones, bone degeneration, orthopedic implant revision, orthopedic initial implantation, and disease; ¶ 442: The bone model of the patient's hip is also utilized to generate a tangible, 3D bone model. In exemplary form, the software is programmed to output the virtual 3D bone model as machine code, thereby allowing rapid prototyping of the tangible 3D bone model, either in an additive or subtractive process … an additive process includes 3D printing where the model is created from a starting blank canvas by the addition of material to form discrete layers or slices of the bone model that, once stacked upon one another by printing successive layers, form the final bone model … a subtractive process includes starting with a solid block of material and, using machine code (e.g., CNC code) to machine away material to arrive at a solid bone model. Those skilled in the art will understand that any number of processes may be utilized to fabricate a tangible bone model; ¶ 447: generate virtual 3D guides that may be utilized to output machine code sufficient to construct a tangible 3D placement guide for the revision cage; ¶ 448: The bone model of the patient's hip is also utilized to generate a tangible, 3D bone model … the software is programmed to output the virtual 3D bone model as machine code, thereby allowing rapid prototyping of the tangible 3D bone model, either in an additive or subtractive process …). Hence, it would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the invention to have used the patient-specific and customized orthopedic implants features of Mahfouz to modify PERLER as claimed because this would amount to no more than applying known techniques to a known device (method, or product) ready for improvement to yield predictable results. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (“The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.”).
PERLER in view of Mahfouz further teaches or at least suggests [(Claim 12)] generating a modified computer model of the osseous anatomy, the modified computer model altered from the computer model of the osseous anatomy such that the modified computer model represents the osseous anatomy after a surgical procedure; and fabricating a postoperative 3D physical bone model comprising a tangible, physical representation of the one or more bones of the osseous anatomy of the patient after the surgical procedure based on the modified computer model (at least PERLER: ¶ 3: Cutting guides are often used to help the surgeon properly locate the cut; ¶ 10: using the cutting guide model to fabricate a cutting guide having the first bone engagement surface, the second bone engagement surface, the first bone attachment feature, the second bone attachment feature, the first guide feature, and the second guide feature; ¶ 16: using at least the first bone model to generate an implant model defining a first bone-facing surface with a first shape that matches a first profile of a first resected surface of the first bone after resection of the first bone with a cutting guide fabricated using the cutting guide model; ¶ 18; ¶ 35: FIGS. 8A, 8B, and 8C are dorsal pre-operative, dorsal post-operative, and lateral post-operative views, respectively, of a foot …; ¶ 36: FIGS. 9A and 9B are dorsal post-operative and lateral post-operative views, respectively, of a foot treated …; ¶ 44: Performance of the step 102 may result in possession of a three-dimensional model of the patient's anatomy, or three-dimensional surface points that can be used to construct such a three-dimensional model; ¶ 48: the model(s) may be used to select from available sizes of implants and/or instruments and advise the surgeon accordingly …where a range of cutting guides are available for a given procedure, analysis of the CAD data may facilitate pre-operative selection of the optimal cutting guide and/or optimal placement of the cutting guide on the bone. Similarly, if a range of implants may be used for a given procedure, analysis of the CAD data may facilitate pre-operative selection of the optimal implant(s); ¶ 63: the degree of angular adjustment needed in each direction may be different for every patient. Use of a patient-specific cutting guide may help the surgeon obtain the optimal realignment in the lateral direction 260 and in the plantar direction 280 or the dorsal direction 290; ¶ 49: the result of the step 108 may be provision, to the surgeon, of one or more of the following: (1) one or more patient-specific instruments; (2) one or more patient-specific implants; (3) an instrument, selected from one or more available instrument sizes and/or configurations; (4) an implant, selected from one or more available implant sizes and/or configurations; (5) instructions for which instrument(s) to select from available instrument sizes and/or configurations; (6) instructions for which implant(s) to select from available implant sizes and/or configurations; (7) instructions for proper positioning or anchorage of one or more instruments to be used in the procedure; and (8) instructions for proper positioning or anchorage of one or more implants to be used in the procedure. These items may be provided to the surgeon directly, or to a medical device company or representative, for subsequent delivery to the surgeon; ¶ 50: In a step 110, the manufactured instrumentation may be used in surgery to facilitate treatment of the condition. In some embodiments, this may entail placing the modelled bone apposition surface against the corresponding contour of the bone used to obtain its shape, and then using the guide feature(s) to guide resection of one or more bones; ¶ 98: FIGS. 8A, 8B, and 8C are dorsal pre-operative, dorsal post-operative, and lateral post-operative views, respectively, of a foot treated with an Evans calcaneal osteotomy; ¶ 99: FIGS. 9A and 9B are dorsal post-operative and lateral post-operative views, respectively, of a foot treated with a medializing calcaneal osteotomy, according to one embodiment. A medializing calcaneal osteotomy (heel slide) procedure is often used when the calcaneus (heel bone) has shifted out from underneath the leg; ¶ 100: FIG. 10 is a rear, perspective view of the foot 200 of FIG. 2, after performance of an Evans calcaneal osteotomy and a medializing calcaneal osteotomy with patient-specific instruments and/or implants; ¶ 101: The cut between the first bone segment 1040 and the second bone segment 1042 may be carried out virtually (for example, in CAD) on a model of the calcaneus 1000 obtained from a CT scan or other imaging of the patient's foot. Thus, the optimal realignment of the posterior end of the calcaneus 1000 can be obtained. If desired, a patient-specific cutting guide, or cutting guide 1043, may be generated in order to facilitate resection of the calcaneus 1000; ¶ 404: As in the case of the Evans calcaneal osteotomy, a custom cutting guide, or cutting guide 1053, may be generated to help the surgeon obtain the correction that was previously modeled and/or planned using the computer models of the foot 200; Mahfouz: ¶ 404: Among these component parts are pre-operative surgical planning, generation of pre-contoured patient-specific trauma plate(s), intra-operative guidance to position and secure the patient-specific trauma plate(s), and optional post-operative evaluation of the patient-specific trauma plate(s); ¶ 461: the clinician testing may be used for more accurate pre-operative and post-operative evaluations; ¶ 464: In addition to pre-operative and post-operative evaluation, the instant system and methods may be useful for intraoperative evaluations. For the patient-specific resection plan, a custom cutting guide is created from the plan and the patient bone data), [(Claim 13)] wherein generating the modified computer model further comprises modifying the computer model in response to user input (at least PERLER: ¶ 5: The surgical procedure may be selected from a first group consisting of a bunion correction osteotomy, an Evans calcaneal osteotomy, and a medializing calcaneal osteotomy. The first bone may be selected from a second group consisting a metatarsus, a cuneiform, and a calcaneus; ¶¶ 48, 49: the model(s) may be used to select from available sizes of implants and/or instruments and advise the surgeon accordingly … if a range of implants may be used for a given procedure, analysis of the CAD data may facilitate pre-operative selection of the optimal implant(s) … instructions for which implant(s) to select from available implant sizes and/or configurations; (7) instructions for proper positioning or anchorage of one or more instruments to be used in the procedure; and (8) instructions for proper positioning or anchorage of one or more implants to be used in the procedure), [(Claim 14)] providing an indicator on one of the preoperative 3D physical bone model and the postoperative 3D physical bone model that distinguishes the preoperative 3D physical bone model from the postoperative 3D physical bone model, [(Claim 15)] wherein the modified computer model is configured to remediate a deformed bone condition of the osseous anatomy (at least PERLER: ¶ 46: any known CAD program may be used to view and/or manipulate the CAD model and/or CT scan, and generate one or more instruments that are matched specifically to the size and/or shape of the patient's bone(s); ¶¶ 73, 74: FIGS. 3A through 3D, the body 310 may further have features that facilitate proper positioning of the cutting guide 300 on the first cuneiform 210 and the first metatarsus 230. More specifically, the body 310 may have a first bone indicator 360 with the text “CUN,” indicating that the end of the body 310 with the first bone indicator 360 is to be positioned over the first cuneiform 210. Similarly, the body 310 may have a second bone indicator 362 with the text “MET,” indicating that the end of the body 310 with the second bone indicator 362 is to be positioned over the first metatarsus 230. In addition, the body 310 may have a side indicator 370 with the text “LEFT,” indicating that the cutting guide 300 is to be used in connection with the patient's left foot. The side indicator 370 may be particularly helpful when bunion corrections are to be provided on both of the patient's feet. In such a case, the surgeon may manufacture or receive two separate cutting guides: one for the left foot (the foot 200 of FIG. 2) and another for the right foot (not shown) …).
In the event the above interpretation is viewed as not being reasonable, as noted earlier, this manufacturing feature appears to amount to no more than repeating the customized manufacturing process of PERLER in view of Mahfouz based on new patient information. Hence, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified PERLER in view of Mahfouz as claimed, because it is well settled that the mere duplication of a known step/part cannot be unobvious absent a showing to the contrary. See Dunbar v. Meyers, 94 U.S. 187, 195 (1876); Slawson v. Grand Street P.P. & F.R. Co., 107 U.S. 649 (1883); Topliff v. Topliff, 145 U.S. 156, 163 (1892); In re Scott, 25 App.D.C. 307 (CADC 1905); In re Volkmann, 28 App.D.C. 441 (CADC 1906); Condit Elec. Mfg. Co. v. Westinghouse Elec. & Mfg. Co., 200 F. 144 (1st Cir. 1912).
[Claim 16] PERLER in view of Mahfouz appears to be silent on the method of claim 11, comprising fabricating a second postoperative 3D physical bone model based on the computer model of the osseous anatomy. However, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the invention, to have modified PERLER in view of Mahfouz as claimed because it is well settled that the mere duplication of a known step/part cannot be unobvious absent a showing to the contrary. See Dunbar v. Meyers, 94 U.S. 187, 195 (1876); Slawson v. Grand Street P.P. & F.R. Co., 107 U.S. 649 (1883); Topliff v. Topliff, 145 U.S. 156, 163 (1892); In re Scott, 25 App.D.C. 307 (CADC 1905); In re Volkmann, 28 App.D.C. 441 (CADC 1906); Condit Elec. Mfg. Co. v. Westinghouse Elec. & Mfg. Co., 200 F. 144 (1st Cir. 1912).
[Claims 17-21] PERLER discloses a method for providing a three-dimensional (3D) physical model for a surgical procedure (at least ¶ 3: Cutting guides are often used to help the surgeon properly locate the cut; ¶¶ 5-11, 13: a method may be used to correct a condition present in a patient … obtaining a first bone model of a first bone of one or more bones of the patient's foot, and using at least the first bone model to generate a cutting guide model … obtaining a second bone model of the metatarsus; ¶ 16: using at least the first bone model to generate an implant model defining a first bone-facing surface with a first shape that matches a first profile of a first resected surface of the first bone after resection of the first bone with a cutting guide fabricated using the cutting guide mode; ; ¶ 44: a three-dimensional model of the patient's anatomy, or three-dimensional surface points that can be used to construct such a three-dimensional model), the method comprising: generating a computer bone model of deformed osseous anatomy of a patient based on medical imaging data of the deformed osseous anatomy (at least ¶ 8: obtaining a second bone model of the metatarsus, and virtually repositioning the second bone model relative to the first bone model to simulate reorientation of the metatarsus relative to the cuneiform to correct the bunion; ¶ 13: Using the first bone model to generate the cutting guide model; ¶ 16: using at least the first bone model to generate an implant model defining a first bone-facing surface with a first shape that matches a first profile of a first resected surface of the first bone after resection of the first bone with a cutting guide fabricated using the cutting guide model; ¶ 18: using the implant model to fabricate an implant having the first bone-facing surface and the second bone-facing surface; ¶ 27: FIG. 1B is a flowchart diagram depicting a method for correcting bunion deformity u of the human foot; ¶ 28: FIG. 2 is a perspective view of a portion of a foot with a bunion deformity to be treated through use of the methods of FIGS. 1A and/or 1B; ¶ 37: FIG. 10 is a rear, perspective view of the foot of FIG. 2, after performance of an Evans calcaneal osteotomy and a medializing calcaneal osteotomy with patient-specific instruments and/or implants; ¶ 38: FIG. 11 is a perspective view of the implant of FIG. 10, in isolation); fabricating a 3D physical bone model of the deformed osseous anatomy based on the computer bone model, wherein the 3D physical bone model comprises a tangible, physical representation of one or more bones of the deformed osseous anatomy of the patient; generating a computer instrument model of an instrument configured for use in a surgical procedure to remediate the deformed osseous anatomy; fabricating the instrument based on the computer instrument model, wherein the instrument is a surgical instrument distinct from the 3D physical bone model; and providing the 3D physical bone model and the instrument to a user (at least ¶¶ 51, 52, 53, 54, 55, 56, 57, 60-64, 69; ¶ 107: Patient-specific cutting guides may be designed, fabricated, and surgically used to facilitate any of these procedures through the presence of bone engagement surfaces that are shaped to rest on the particular bony surfaces adjacent to the osteotomy; ¶¶ 76-78: pins 500 may be inserted through the holes 340 in the body 310 and anchored in the first cuneiform 210 and the first metatarsus 230. Each of the pins 500 may have a sharp and/or threaded distal end that can penetrate and/or readily be retained in the bone of the first cuneiform 210 or the first metatarsus 230. Additionally or alternatively, a drill or other hole-forming instrument may be used to pre-form holes in the first cuneiform 210 and/or the first metatarsus 230 to receive the distal ends of the pins 50 …; ¶ 101: The cut between the first bone segment 1040 and the second bone segment 1042 may be carried out virtually (for example, in CAD) on a model of the calcaneus 1000 obtained from a CT scan or other imaging of the patient's foot; ¶ 105: the model of the calcaneus 1000 may be divided and manipulated in CAD to simulate the repositioning of the heel 1050 pursuant to the medializing calcaneal osteotomy; ¶ 111: the bone plate 1070 may also be fabricated specifically for the foot 200, enabling the bone plate 1070 to maintain precisely the desired level of correction. When made specifically for the foot 200 in combination with each other, the implant 1060 and the bone plate 1070 may provide a highly predictable, precise, and customizable level of correction of the flat foot deformity).
Alternatively, in the event the above interpretation of PERLER in regard to wherein the 3D physical bone model comprises a tangible, physical representation of one or more bones of the deformed osseous anatomy of the patient is viewed as not being reasonable, Mahfouz teaches or at least suggests tangible, physical representation of one or more bones of the deformed osseous anatomy of the patient (at least ¶ 206: FIGS. 1-8, reconstruction of a deformed anatomy or a partial anatomy is one of the complex problems facing healthcare providers. Loss of anatomy may be the result of birth conditions, tumors, diseases, personal injuries, or failure of previous surgeries. As part of providing treatment for various ailments, healthcare providers may find it advantageous to reconstruct an anatomy or construct an anatomy to facilitate treatment for various conditions that may include, without limitation, broken/shattered bones, bone degeneration, orthopedic implant revision, joint degeneration, and custom instrumentation design; ¶ 207: FIGS. 1-8, reconstruction of a deformed anatomy or a partial anatomy is one of the complex problems facing healthcare providers. Loss of anatomy may be the result of birth conditions, tumors, diseases, personal injuries, or failure of previous surgeries. As part of providing treatment for various ailments, healthcare providers may find it advantageous to reconstruct an anatomy or construct an anatomy to facilitate treatment for various conditions that may include, without limitation, broken/shattered bones, bone degeneration, orthopedic implant revision, joint degeneration, and custom instrumentation design; ¶ 212: This 3D model is a full, normal reconstruction of the bone(s) in question …; ¶ 244: Regardless of the context, whether partial, deformed, and/or shattered anatomies of the patient are at issue, the exemplary system and process for generating patient-specific implants and/or guides utilizes the foregoing exemplary process and system of 3D bone model reconstruction (see FIGS. 1-7 and the foregoing exemplary discussion of the same) to generate a three dimensional model of the patient's reconstructed anatomy; ¶ 424: The input anatomy data is utilized to construct a three dimensional virtual model of the fractured anatomy …; ¶ 430: As part of providing treatment for various ailments, healthcare providers may find it advantageous to reconstruct an anatomy or construct an anatomy to facilitate treatment for various conditions that may include, without limitation, broken/shattered bones, bone degeneration, orthopedic implant revision, orthopedic initial implantation, and disease; ¶ 442: The bone model of the patient's hip is also utilized to generate a tangible, 3D bone model. In exemplary form, the software is programmed to output the virtual 3D bone model as machine code, thereby allowing rapid prototyping of the tangible 3D bone model, either in an additive or subtractive process … an additive process includes 3D printing where the model is created from a starting blank canvas by the addition of material to form discrete layers or slices of the bone model that, once stacked upon one another by printing successive layers, form the final bone model … a subtractive process includes starting with a solid block of material and, using machine code (e.g., CNC code) to machine away material to arrive at a solid bone model. Those skilled in the art will understand that any number of processes may be utilized to fabricate a tangible bone model; ¶ 447: generate virtual 3D guides that may be utilized to output machine code sufficient to construct a tangible 3D placement guide for the revision cage; ¶ 448: The bone model of the patient's hip is also utilized to generate a tangible, 3D bone model … the software is programmed to output the virtual 3D bone model as machine code, thereby allowing rapid prototyping of the tangible 3D bone model, either in an additive or subtractive process …). Hence, it would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the invention to have used the patient-specific and customized orthopedic implants features of Mahfouz to modify PERLER as claimed because this would amount to no more than applying known techniques to a known device (method, or product) ready for improvement to yield predictable results. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (“The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.”).
[Claims 18-21] PERLER in view of Mahfouz teaches or at least suggests wherein the instrument is a patient-specific instrument comprising a bone engagement member configured to engage a bone of the deformed osseous anatomy and to engage a physical bone model of the 3D physical bone model corresponding to the bone of the deformed osseous anatomy, [(Claim 19)] a first 3D physical bone model comprising a tangible, physical representation of one or more bones of deformed osseous anatomy of a patient for an osteotomy procedure; a preoperative plan for the osteotomy procedure; and a set of patient-specific instruments for one or more stages of the osteotomy procedure (at least ¶ 7: The first guide feature may be positioned to guide resection of the cuneiform. The cutting guide model may further define a second bone engagement surface shaped to match a second contour of the metatarsus, and a second guide feature that, with the second bone engagement surface overlying the second contour, is positioned to guide resection of the metatarsus; ¶ 8: obtaining a second bone model of the metatarsus, and virtually repositioning the second bone model relative to the first bone model to simulate reorientation of the metatarsus relative to the cuneiform to correct the bunion; FIGS. 3A through 3D and associated text; FIG 10 and associated text; ¶ 40: … interaction between two or more entities, including mechanical, electrical, magnetic, electromagnetic, fluid, and thermal interaction … ; ¶¶ 76-78: pins 500 may be inserted through the holes 340 in the body 310 and anchored in the first cuneiform 210 and the first metatarsus 230. Each of the pins 500 may have a sharp and/or threaded distal end that can penetrate and/or readily be retained in the bone of the first cuneiform 210 or the first metatarsus 230. Additionally or alternatively, a drill or other hole-forming instrument may be used to pre-form holes in the first cuneiform 210 and/or the first metatarsus 230 to receive the distal ends of the pins 50 …), [(Claim 20)] a second 3D physical bone model comprising a plurality of physical bone models coupled by way of a plurality of interconnects, the plurality of physical bone models coupled according to a predetermined configuration, [(Claim 21)] wherein the predetermined configuration is selected from the group comprising an anatomical position, a normal position, a weight bearing position, one stage of a walking position, one stage of a running position, one stage of a jumping position, one stage of a grasping position, a dorsiflexed position, a plantar flexed position, a laterally rotated position, a medially rotated position, an eversion rotated position, an inversion rotated position, a deformed condition, a corrected condition, a preoperative condition, and a postoperative condition (at least ¶ 19: surgical osteotomy may be selected from a first group consisting of a bunion correction osteotomy, an Evans calcaneal osteotomy, and a medializing calcaneal osteotomy. The first bone may be selected from a second group consisting of a metatarsus, a cuneiform, and a calcaneus; ¶ 46: any known CAD program may be used to view and/or manipulate the CAD model and/or CT scan, and generate one or more instruments that are matched specifically to the size and/or shape of the patient's bone(s); ¶ 56: manufacturing the cutting guide with the bone apposition surface and the guide features as described above. As in the step 108, the step 128 may additionally or alternatively involve provision of one or more instruments and/or implants from among a plurality of predetermined configurations or sizes; FIGs 2, 4, 6A through 6C, 8A through 8C, 9A, 9B, 10 and associated text). Any differences in the above would have been an obvious matter of choice.
Response to Arguments
Rejections under 35 U.S.C. § 102, 35 U.S.C. § 102/103 and 35 U.S.C. § 103
Applicant’s arguments have been fully considered but are moot in view of new grounds of rejections necessitated by Applicant’s amendment.
Conclusion
The prior art made of record and not relied upon is listed in the attached PTO Form 892 and is considered pertinent to applicant's disclosure.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/EDDY SAINT-VIL/Primary Examiner, Art Unit 3715
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