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 .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/30/25 has been entered.
Response to Arguments
Response: 35 U.S.C. § 112
1. Examiner Response:
Applicant’s arguments, see page 8, filed 10/30/25, with respect to the 35 U.S.C. 112(a) and 35 U.S.C. 112(b) rejections have been fully considered and are persuasive. The 35 U.S.C. 112(a) and 35 U.S.C. 112(b) rejections of claims 5, 30-34, 37-38 and 41-42 has been withdrawn.
Response: 35 U.S.C. § 101
2. Applicants argue:
The applicant argues that with the recent amendment to the claims, the claims are not directed towards an abstract idea, where it does not fall within the “Mental Process” grouping of an abstract idea. The applicant argues that the claim features require a computer system to execute the limitations of the claims. (Remarks: pages 8-12)
3. Examiner Response:
The examiner notes that the limitation of claim 1 that states “generating at least one shape and curvature of a fixation rod that is fixed with and mimics the morphology of the patient” doesn’t distinguish itself from being able to be conducted in the human mind or with pencil and paper. Therefore, under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
Also, the limitation of “inputting into a computer system, wherein the computer system comprises a processor, a non-transitory memory and an artificial intelligence program, data from pre-surgical measurements of spinal curvature of a patient” amounts to insignificant extra-solution activity of receiving data i.e. pre-solution activity of gathering data for use in the claimed process, see MPEP 2106.05(g).
Also, the limitation of “running an osteotomy simulation with the computer system
based on the inputted data, including generating a morphology of the patient based on the inputted data” amounts to mere instructions to apply an exception, where it recites an idea of a solution. The limitation doesn’t indicate what the inputted data is or how the morphology of the patient is being generated. See MPEP 2106.05 (f) (1) Whether the claim recites only the idea of a solution or outcome i.e., the claim fails to recite details of how a solution to a problem is accomplished. The recitation of claim limitations that attempt to cover any solution to an identified problem with no restriction on how the result is accomplished and no description of the mechanism for accomplishing the result, does not integrate a judicial exception into a practical application or provide significantly more because this type of recitation is equivalent to the words "apply it".
Also, the limitation of “predicting loading including at least one of a loading in the fixation rod and a loading from the fixation rod to the morphology” amounts to insignificant extra-solution activity of receiving data i.e. pre-solution activity of gathering data for use in the claimed process, see MPEP 2106.05(g).
Also, the limitation of “and determining a fixation rod morphotype from the at least one shape and curvature, the fixation rod morphotype including at least one diameter based on the predicted loading” amounts to mere instructions to apply an exception, where it recites an idea of a solution. The limitation doesn’t indicate how the determining of a fixation rod morphotype is being conducted. See MPEP 2106.05 (f) (1) Whether the claim recites only the idea of a solution or outcome i.e., the claim fails to recite details of how a solution to a problem is accomplished. The recitation of claim limitations that attempt to cover any solution to an identified problem with no restriction on how the result is accomplished and no description of the mechanism for accomplishing the result, does not integrate a judicial exception into a practical application or provide significantly more because this type of recitation is equivalent to the words "apply it".
Also, the limitation of “preoperatively machining the fixation rod including the fixation rod morphotype, and then intraoperatively bending the fixation rod to the at least one shape and curvature” amounts to mere instructions to apply an exception, where it recites an idea of a solution. The limitation doesn’t indicate how the fixation rod is being bent. See MPEP 2106.05 (f) (1) Whether the claim recites only the idea of a solution or outcome i.e., the claim fails to recite details of how a solution to a problem is accomplished. The recitation of claim limitations that attempt to cover any solution to an identified problem with no restriction on how the result is accomplished and no description of the mechanism for accomplishing the result, does not integrate a judicial exception into a practical application or provide significantly more because this type of recitation is equivalent to the words "apply it".
Also, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The additional elements of the processor and computer that applies a judicial exception, such as an abstract idea, by use of conventional computer functions does not qualify as a particular machine, see MPEP 2106.05(b) 1. It is important to note that a general purpose computer that applies a judicial exception, such as an abstract idea, by use of conventional computer functions does not qualify as a particular machine. Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709, 716-17, 112 USPQ2d 1750, 1755-56 (Fed. Cir. 2014). See also TLI Communications LLC v. AV Automotive LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (mere recitation of concrete or tangible components is not an inventive concept); Eon Corp. IP Holdings LLC v. AT&T Mobility LLC, 785 F.3d 616, 623, 114 USPQ2d 1711, 1715 (Fed. Cir. 2015) (noting that Alappat’s rationale that an otherwise ineligible algorithm or software could be made patent-eligible by merely adding a generic computer to the claim was superseded by the Supreme Court’s Bilski and Alice Corp. decisions).
Further, the claim recites the additional elements of a processor and memory. The processor and memory are recited at a high level of generality such that it amounts no more than mere instructions to apply the exception using a computer and/or a generic computer component. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
Response: 35 U.S.C. § 103
4. The examiner response regarding the applicant’s arguments to the newly added limitations are shown below.
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 1-7 and 30-42 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Under the broadest reasonable interpretation, the claims covers performance of the limitation in the mind or by pencil and paper and as a mathematical concept.
Claim 1
Regarding step 1, claim 1 is directed towards a method which has the claims fall within the eligible statutory categories of processes, machines, manufactures and composition of matter under 35 U.S.C. 101.
Claim 1
Regarding step 2A, prong 1, claim 1 recites “generating at least one shape and curvature of a fixation rod that is fixed with and mimics the morphology of the patient”. This limitation doesn’t distinguish itself from being able to be conducted in the human mind or with pencil and paper. Therefore, under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
Regarding step 2A, prong 2, the limitation of “inputting into a computer system, wherein the computer system comprises a processor, a non-transitory memory and an artificial intelligence program, data from pre-surgical measurements of spinal curvature of a patient” amounts to insignificant extra-solution activity of receiving data i.e. pre-solution activity of gathering data for use in the claimed process, see MPEP 2106.05(g).
Also, the limitation of “running an osteotomy simulation with the computer system
based on the inputted data, including generating a morphology of the patient based on the inputted data” amounts to mere instructions to apply an exception, where it recites an idea of a solution. The limitation doesn’t indicate what the inputted data is or how the morphology of the patient is being generated. See MPEP 2106.05 (f) (1) Whether the claim recites only the idea of a solution or outcome i.e., the claim fails to recite details of how a solution to a problem is accomplished. The recitation of claim limitations that attempt to cover any solution to an identified problem with no restriction on how the result is accomplished and no description of the mechanism for accomplishing the result, does not integrate a judicial exception into a practical application or provide significantly more because this type of recitation is equivalent to the words "apply it".
Also, the limitation of “predicting loading including at least one of a loading in the fixation rod and a loading from the fixation rod to the morphology” amounts to insignificant extra-solution activity of receiving data i.e. pre-solution activity of gathering data for use in the claimed process, see MPEP 2106.05(g).
Also, the limitation of “and determining a fixation rod morphotype from the at least one shape and curvature, the fixation rod morphotype including at least one diameter based on the predicted loading” amounts to mere instructions to apply an exception, where it recites an idea of a solution. The limitation doesn’t indicate how the determining of a fixation rod morphotype is being conducted. See MPEP 2106.05 (f) (1) Whether the claim recites only the idea of a solution or outcome i.e., the claim fails to recite details of how a solution to a problem is accomplished. The recitation of claim limitations that attempt to cover any solution to an identified problem with no restriction on how the result is accomplished and no description of the mechanism for accomplishing the result, does not integrate a judicial exception into a practical application or provide significantly more because this type of recitation is equivalent to the words "apply it".
Also, the limitation of “preoperatively machining the fixation rod including the fixation rod morphotype, and then intraoperatively bending the fixation rod to the at least one shape and curvature” amounts to mere instructions to apply an exception, where it recites an idea of a solution. The limitation doesn’t indicate how the fixation rod is being bent. See MPEP 2106.05 (f) (1) Whether the claim recites only the idea of a solution or outcome i.e., the claim fails to recite details of how a solution to a problem is accomplished. The recitation of claim limitations that attempt to cover any solution to an identified problem with no restriction on how the result is accomplished and no description of the mechanism for accomplishing the result, does not integrate a judicial exception into a practical application or provide significantly more because this type of recitation is equivalent to the words "apply it".
Also, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The additional elements of the processor and computer that applies a judicial exception, such as an abstract idea, by use of conventional computer functions does not qualify as a particular machine, see MPEP 2106.05(b) 1. It is important to note that a general purpose computer that applies a judicial exception, such as an abstract idea, by use of conventional computer functions does not qualify as a particular machine. Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709, 716-17, 112 USPQ2d 1750, 1755-56 (Fed. Cir. 2014). See also TLI Communications LLC v. AV Automotive LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (mere recitation of concrete or tangible components is not an inventive concept); Eon Corp. IP Holdings LLC v. AT&T Mobility LLC, 785 F.3d 616, 623, 114 USPQ2d 1711, 1715 (Fed. Cir. 2015) (noting that Alappat’s rationale that an otherwise ineligible algorithm or software could be made patent-eligible by merely adding a generic computer to the claim was superseded by the Supreme Court’s Bilski and Alice Corp. decisions).
Further, the claim recites the additional elements of a processor and memory. The processor and memory are recited at a high level of generality such that it amounts no more than mere instructions to apply the exception using a computer and/or a generic computer component. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
Regarding Step 2B, the limitation of “inputting into a computer system, wherein the computer system comprises a processor, a non-transitory memory and an artificial intelligence program, data from pre-surgical measurements of spinal curvature of a patient” is also shown to reflect the court decisions of Versata Dev. Group, Inc. v. SAP Am., Inc. iv. Storing and retrieving information in memory, shown in MPEP 2106.05(d) (II).
Also, the limitation of “running an osteotomy simulation with the computer system
based on the inputted data, including generating a morphology of the patient based on the inputted data” amounts to mere instructions to apply an exception, where it recites an idea of a solution. The limitation doesn’t indicate what the inputted data is or how the morphology of the patient is being generated. See MPEP 2106.05 (f) (1) Whether the claim recites only the idea of a solution or outcome i.e., the claim fails to recite details of how a solution to a problem is accomplished. The recitation of claim limitations that attempt to cover any solution to an identified problem with no restriction on how the result is accomplished and no description of the mechanism for accomplishing the result, does not integrate a judicial exception into a practical application or provide significantly more because this type of recitation is equivalent to the words "apply it".
Also, the limitation of “predicting loading including at least one of a loading in the fixation rod and a loading from the fixation rod to the morphology” is also shown to reflect the court decisions of Versata Dev. Group, Inc. v. SAP Am., Inc. iv. Storing and retrieving information in memory, shown in MPEP 2106.05(d) (II).
Also, the limitation of “and determining a fixation rod morphotype from the at least one shape and curvature, the fixation rod morphotype including at least one diameter based on the predicted loading” amounts to mere instructions to apply an exception, where it recites an idea of a solution. The limitation doesn’t indicate how the determining of a fixation rod morphotype is being conducted. See MPEP 2106.05 (f) (1) Whether the claim recites only the idea of a solution or outcome i.e., the claim fails to recite details of how a solution to a problem is accomplished. The recitation of claim limitations that attempt to cover any solution to an identified problem with no restriction on how the result is accomplished and no description of the mechanism for accomplishing the result, does not integrate a judicial exception into a practical application or provide significantly more because this type of recitation is equivalent to the words "apply it".
Also, the limitation of “preoperatively machining the fixation rod including the fixation rod morphotype, and then intraoperatively bending the fixation rod to the at least one shape and curvature” amounts to mere instructions to apply an exception, where it recites an idea of a solution. The limitation doesn’t indicate how the fixation rod is being bent. See MPEP 2106.05 (f) (1) Whether the claim recites only the idea of a solution or outcome i.e., the claim fails to recite details of how a solution to a problem is accomplished. The recitation of claim limitations that attempt to cover any solution to an identified problem with no restriction on how the result is accomplished and no description of the mechanism for accomplishing the result, does not integrate a judicial exception into a practical application or provide significantly more because this type of recitation is equivalent to the words "apply it".
Also, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of a processor and memory amounts no more than mere instructions to apply the exception using a generic computer component that does not impose any meaningful limits on practicing the abstract idea and therefore cannot provide an inventive concept (See MPEP 2106.05(b).
Claim 2
Dependent claim 2 recites “implanting the fixation rod”. This limitation doesn’t distinguish itself from being able to be conducted in the human mind or with pencil and paper. Therefore, under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
Also, the limitation of “implanting the fixation rod” amounts to mere instructions to apply an exception, where it recites an idea of a solution. The limitation doesn’t indicate how the implanting is being conducted. See MPEP 2106.05 (f) (1) Whether the claim recites only the idea of a solution or outcome i.e., the claim fails to recite details of how a solution to a problem is accomplished. The recitation of claim limitations that attempt to cover any solution to an identified problem with no restriction on how the result is accomplished and no description of the mechanism for accomplishing the result, does not integrate a judicial exception into a practical application or provide significantly more because this type of recitation is equivalent to the words "apply it".
Dependent claim 2 recites “wherein the at least one shape and curvature of the fixation rod is a single rod that is monolithically formed and runs along the morphology of the patient including a spinal column in a direction from an occiput toward a sacrum in the patient.”.
Dependent claim 2 recites “and the at least one shape and curvature is positioned above or below a thoracolumbar junction or cervical thoracic junction in the patient morphology”. This limitation doesn’t distinguish itself from being able to be conducted in the human mind or with pencil and paper. Therefore, under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
Claim 3
Dependent claim 3 recites “wherein the at least one shape and curvature of the fixation rod comprises a plurality of sections, the plurality of sections each comprise different diameters.”. Under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
Dependent claim 3 recites “and running the osteotomy simulation also includes performing the at least one determination includes determining a variable bending stiffness or a flex of the fixation rod along the morphology based on a local diameter of each of the sections”. This limitation amounts to mere instructions to apply an exception, where it recites an idea of a solution. The limitation doesn’t indicate how the variable bending stiffness is being determined or how a flex of the fixation rod being determined. See MPEP 2106.05 (f) (1) Whether the claim recites only the idea of a solution or outcome i.e., the claim fails to recite details of how a solution to a problem is accomplished. The recitation of claim limitations that attempt to cover any solution to an identified problem with no restriction on how the result is accomplished and no description of the mechanism for accomplishing the result, does not integrate a judicial exception into a practical application or provide significantly more because this type of recitation is equivalent to the words "apply it".
Claim 4
Dependent claim 4 recites “wherein the at least one shape and curvature of the fixation rod comprises transition region positioned between the plurality of sections”. Under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
Dependent claim 4 recites “the transition region gradually varies in diameter between the plurality of sections along a longitudinal axis of the fixation rod based on the osteotomy simulation.”. Under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
Dependent claim 4 recites “running the osteotomy simulation includes predicting the variable bending stiffness or the flex of the fixation rod along the morphology at the transition region based on the diameter of the fixation rod morphotype along the transition region”. This limitation amounts to mere instructions to apply an exception, where it recites an idea of a solution. The limitation doesn’t indicate how the diameter of the fixation rod morphotype is associated with the variable bending stiffness or the flex of the fixation rod. See MPEP 2106.05 (f) (1) Whether the claim recites only the idea of a solution or outcome i.e., the claim fails to recite details of how a solution to a problem is accomplished. The recitation of claim limitations that attempt to cover any solution to an identified problem with no restriction on how the result is accomplished and no description of the mechanism for accomplishing the result, does not integrate a judicial exception into a practical application or provide significantly more because this type of recitation is equivalent to the words "apply it".
Claim 5
Dependent claim 5 recites “generating fixation devices in the osteotomy simulation”. This limitation is viewed as merely reciting the words “apply it” or an equivalent, where the generating of a fixation device is based on the input data of pre-surgical measurements, see MPEP 2106.05(f) “(3) The particularity or generality of the application of the judicial exception. A claim having broad applicability across many fields of endeavor may not provide meaningful limitations that integrate a judicial exception into a practical application or amount to significantly more. For instance, a claim that generically recites an effect of the judicial exception or claims every mode of accomplishing that effect, amounts to a claim that is merely adding the words "apply it" to the judicial exception.”.
Dependent claim 5 recites “wherein running the osteotomy simulation includes predicting at least one of the loading in the fixation rod between the fixation devices, and the loading from the fixation rod to the morphology through the fixation devices at predetermined locations”. This limitation amounts to mere instructions to apply an exception, where it recites an idea of a solution. The limitation doesn’t indicate how the loading in the fixation rod is being conducted. See MPEP 2106.05 (f) (1) Whether the claim recites only the idea of a solution or outcome i.e., the claim fails to recite details of how a solution to a problem is accomplished. The recitation of claim limitations that attempt to cover any solution to an identified problem with no restriction on how the result is accomplished and no description of the mechanism for accomplishing the result, does not integrate a judicial exception into a practical application or provide significantly more because this type of recitation is equivalent to the words "apply it".
Dependent claim 5 recites and physically forming the fixation devices generated in the osteotomy simulation, and then implanting the fixation rod and the fixation devices”. This limitation amounts to mere instructions to apply an exception, where it recites an idea of a solution. The limitation doesn’t indicate how the fixation devices are being physically formed. See MPEP 2106.05 (f) (1) Whether the claim recites only the idea of a solution or outcome i.e., the claim fails to recite details of how a solution to a problem is accomplished. The recitation of claim limitations that attempt to cover any solution to an identified problem with no restriction on how the result is accomplished and no description of the mechanism for accomplishing the result, does not integrate a judicial exception into a practical application or provide significantly more because this type of recitation is equivalent to the words "apply it".
Dependent claim 5 recites “wherein the fixation devices engage the fixation rod and fix the fixation rod to the predetermined locations on the patient”. This limitation amounts to mere instructions to apply an exception, where it recites an idea of a solution. The limitation doesn’t indicate how the fixation devices are attaches the fixation rod and fixes the fixation rod to the predetermined locations on the patient. See MPEP 2106.05 (f) (1) Whether the claim recites only the idea of a solution or outcome i.e., the claim fails to recite details of how a solution to a problem is accomplished. The recitation of claim limitations that attempt to cover any solution to an identified problem with no restriction on how the result is accomplished and no description of the mechanism for accomplishing the result, does not integrate a judicial exception into a practical application or provide significantly more because this type of recitation is equivalent to the words "apply it".
Claim 6
Dependent claim 6 recites “wherein the at least one shape and curvature of the fixation rod comprises a plurality of sections that each comprise different diameters determined based on the predicted loading”. Under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
Dependent claim 6 recites “and each of the different diameters is constant along a longitudinal axis of the fixation rod.”. Under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
Claim 7
Dependent claim 7 recites “wherein the at least one shape and curvature of the fixation rod comprises a plurality of transition regions positioned between the plurality of sections”. Under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
Dependent claim 7 recites “and wherein of each transition extends region along a longitudinal axis of the fixation rod is defined by a Bezier curve and determining the fixation rod morphotype in the osteotomy simulation includes calculating the Bezier curve.”. Under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
Claim 30
Dependent claim 30 recites “wherein the transition region is tapered along the
longitudinal direction of the fixation rod from a first diameter at a first section of the plurality of sections to a second diameter at a second section of the plurality of sections”. Under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
Dependent claim 30 recites “performing the osteotomy simulation includes predicting the loading using an algorithm to calculate the diameter of the transition region from the first diameter to the second diameter based on the pre-surgical measurements and the fixation rod”. This limitation is using an algorithm to calculate the diameter of the transition region from the first diameter to the second diameter. Therefore, under MPEP 2106.04(a)(2), this limitation covers a mathematical concept, which falls in the “Mathematical Concept” grouping of abstract ideas.
Dependent claim 30 recites “generating the at least one shape and curvature includes determining the first diameter, the second diameter, or a length of the transition region based on the predicted loading.”. This limitation amounts to mere instructions to apply an exception, where it recites an idea of a solution. The limitation doesn’t indicate how the first diameter, the second diameter, or a length of the transition region are being determined. See MPEP 2106.05 (f) (1) Whether the claim recites only the idea of a solution or outcome i.e., the claim fails to recite details of how a solution to a problem is accomplished. The recitation of claim limitations that attempt to cover any solution to an identified problem with no restriction on how the result is accomplished and no description of the mechanism for accomplishing the result, does not integrate a judicial exception into a practical application or provide significantly more because this type of recitation is equivalent to the words "apply it".
Claim 31
Dependent claim 31 recites “wherein running the osteotomy simulation includes generating fixation devices that attach the fixation rod to the morphology of the patient”. This limitation amounts to mere instructions to apply an exception, where it recites an idea of a solution. The limitation doesn’t indicate how the fixation devices are generated. See MPEP 2106.05 (f) (1) Whether the claim recites only the idea of a solution or outcome i.e., the claim fails to recite details of how a solution to a problem is accomplished. The recitation of claim limitations that attempt to cover any solution to an identified problem with no restriction on how the result is accomplished and no description of the mechanism for accomplishing the result, does not integrate a judicial exception into a practical application or provide significantly more because this type of recitation is equivalent to the words "apply it".
Dependent claim 31 recites “then predicting the loading in the fixation rod between the fixation devices along the morphology, or predicting the loading from the fixation rod to the morphology through the fixation devices”. This limitation amounts to mere instructions to apply an exception, where it recites an idea of a solution. The limitation doesn’t indicate how the loading in the fixation rod is being conducted. See MPEP 2106.05 (f) (1) Whether the claim recites only the idea of a solution or outcome i.e., the claim fails to recite details of how a solution to a problem is accomplished. The recitation of claim limitations that attempt to cover any solution to an identified problem with no restriction on how the result is accomplished and no description of the mechanism for accomplishing the result, does not integrate a judicial exception into a practical application or provide significantly more because this type of recitation is equivalent to the words "apply it".
Dependent claim 31 recites “and determining a location of the fixation devices relative to the fixation rod and the morphology of the patient based on the predicted loading.”. Under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
Claim 32
Dependent claim 32 recites “wherein running the osteotomy simulation includes predicting a stress or strain in the fixation rod or the fixation devices at segments adjacent to the transition region based on the diameter of the transition region, the morphology of the patient, and the predicted loading”. This limitation amounts to mere instructions to apply an exception, where it recites an idea of a solution. The limitation doesn’t indicate how the stress or strain in the fixation rod or the fixation devices are associated with the morphology of the patient, and the predicted loading. See MPEP 2106.05 (f) (1) Whether the claim recites only the idea of a solution or outcome i.e., the claim fails to recite details of how a solution to a problem is accomplished. The recitation of claim limitations that attempt to cover any solution to an identified problem with no restriction on how the result is accomplished and no description of the mechanism for accomplishing the result, does not integrate a judicial exception into a practical application or provide significantly more because this type of recitation is equivalent to the words "apply it".
Dependent claim 32 recites “and determining the location of the fixation devices includes determining the location of the fixation devices along the transition region, or at an intersection of the transition region and the first section or the second section based on the predicted loading”. Under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
Also, the limitation amounts to mere instructions to apply an exception, where it recites an idea of a solution. The limitation doesn’t indicate how the location of the fixation devices along the transition region, or at an intersection of the transition region are being determined.
Claim 33
Dependent claim 33 recites “implanting the fixation rod and the fixation device in the patient”. This limitation amounts to merely indicating a field of use. In MPEP 2106.05(h) it states “Thus, limitations that amount to merely indicating a field of use or technological environment in which to apply a judicial exception do not amount to significantly more than the exception itself, and cannot integrate a judicial exception into a practical application”.
Dependent claim 33 recites “wherein the fixation device is a pedicle assembly attached to the fixation rod and the patient at the determined location”. This limitation amounts to merely indicating a field of use. In MPEP 2106.05(h) it states “Thus, limitations that amount to merely indicating a field of use or technological environment in which to apply a judicial exception do not amount to significantly more than the exception itself, and cannot integrate a judicial exception into a practical application”.
Claim 34
Dependent claim 34 recites “wherein the transition region has a frusto-conical shape extended from a first section of the plurality of sections to a second section of the plurality of sections.”. Under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
Dependent claim 34 recites “determining the morphotype includes determining each of the first diameter and the second diameter to be at least 3mm and at most 6mm, with a maximum difference between the first diameter and the second diameter being 1mm, and a length of the frusto-conical shape to be at least 5mm and at most 40mm based on the predicted loading in the fixation rod along the frusto-conical shape, and based on the predicted variable bending stiffness or the predicted flex of the fixation rod along the frusto-conical shape”. This limitation doesn’t distinguish itself from being able to be conducted in the human mind or with pencil and paper. Therefore, under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
Dependent claim 34 recites “and determining the at least one shape and curvature includes determining a bend in the transition region of at least 1° and at most 90° based on the predicted loading in the fixation rod along the frusto-conical shape”. This limitation amounts to mere instructions to apply an exception, where it recites an idea of a solution. The limitation doesn’t indicate how the bend in the transition region is determined to be of at least 1° and at most 90°. See MPEP 2106.05 (f) (1) Whether the claim recites only the idea of a solution or outcome i.e., the claim fails to recite details of how a solution to a problem is accomplished. The recitation of claim limitations that attempt to cover any solution to an identified problem with no restriction on how the result is accomplished and no description of the mechanism for accomplishing the result, does not integrate a judicial exception into a practical application or provide significantly more because this type of recitation is equivalent to the words "apply it".
Claim 35
Dependent claim 35 recites “determining a custom shape of the fixation rod for the patient as the at least one shape and curvature”. This limitation doesn’t distinguish itself from being able to be conducted in the human mind or with pencil and paper. Therefore, under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
Dependent claim 35 recites “and implanting the fixation rod, including intraoperatively modifying the fixation rod from the determined fixation rod morphotype to the custom shape by sizing the fixation rod down with a desired taper or curvature, turning the fixation rod, or adding a curve or a tapered segment to the fixation rod”. This limitation is viewed as merely reciting the words “apply it” or an equivalent, where the implanting of the fixation rod, including sizing the fixation rod down with a desired taper or curvature, turning the fixation rod, or adding a curve or a tapered segment to the fixation rod is based on the simulation, see MPEP 2106.05(f) “(3) The particularity or generality of the application of the judicial exception. A claim having broad applicability across many fields of endeavor may not provide meaningful limitations that integrate a judicial exception into a practical application or amount to significantly more. For instance, a claim that generically recites an effect of the judicial exception or claims every mode of accomplishing that effect, amounts to a claim that is merely adding the words "apply it" to the judicial exception.”.
Also, the limitation of “and implanting the fixation rod, including intraoperatively modifying the fixation rod from the determined fixation rod morphotype to the custom shape by sizing the fixation rod down with a desired taper or curvature, turning the fixation rod, or adding a curve or a tapered segment to the fixation rod” amounts to mere instructions to apply an exception, where it recites an idea of a solution, see MPEP 2106.05 (f) (1) Whether the claim recites only the idea of a solution or outcome i.e., the claim fails to recite details of how a solution to a problem is accomplished. The recitation of claim limitations that attempt to cover any solution to an identified problem with no restriction on how the result is accomplished and no description of the mechanism for accomplishing the result, does not integrate a judicial exception into a practical application or provide significantly more because this type of recitation is equivalent to the words "apply it".
Claim 36
Dependent claim 36 recites “implanting the fixation rod, including augmenting a flex of the fixation rod to the morphology of the patient by on site intraoperative modification adding a curve to the fixation rod along a longitudinal axis of the fixation rod.”. This limitation is viewed as merely reciting the words “apply it” or an equivalent, where the implanting of the fixation rod, including augmenting a flex of the fixation rod to the morphology of the patient by on site intraoperative modification adding a curve to the fixation rod along a longitudinal axis is based on the simulation, see MPEP 2106.05(f) “(3) The particularity or generality of the application of the judicial exception. A claim having broad applicability across many fields of endeavor may not provide meaningful limitations that integrate a judicial exception into a practical application or amount to significantly more. For instance, a claim that generically recites an effect of the judicial exception or claims every mode of accomplishing that effect, amounts to a claim that is merely adding the words "apply it" to the judicial exception.”.
Claim 37
Dependent claim 37 recites “wherein the morphology includes a spinal column of the patient”. Under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
Dependent claim 37 recites “and running the osteotomy simulation includes: predicting the loading from the fixation rod to the spinal column of the patient, including load transfer to a portion of the spinal column stabilized by the fixation rod, and load transfer to vertebral segments adjacent to the portion of the spinal column”. The predicting of the load transfer involves computing the load transfer. Therefore, under MPEP 2106.04(a)(2), this limitation covers a mathematical concept, which falls in the “Mathematical Concept” grouping of abstract ideas.
Also, this limitation amounts to mere instructions to apply an exception, where it recites an idea of a solution. The limitation doesn’t indicate how the load transfer is directed towards a portion of the spinal column stabilized by the fixation rod. See MPEP 2106.05 (f) (1) Whether the claim recites only the idea of a solution or outcome i.e., the claim fails to recite details of how a solution to a problem is accomplished. The recitation of claim limitations that attempt to cover any solution to an identified problem with no restriction on how the result is accomplished and no description of the mechanism for accomplishing the result, does not integrate a judicial exception into a practical application or provide significantly more because this type of recitation is equivalent to the words "apply it".
Dependent claim 37 recites “and generating at least one of a length, diameter, curvature, and slope of the fixation rod at the portion of the spinal column based on the predicted loading.”. This limitation amounts to mere instructions to apply an exception, where it recites an idea of a solution. The limitation doesn’t indicate how a length, diameter, curvature, and slope of the fixation rod are being generated. See MPEP 2106.05 (f) (1) Whether the claim recites only the idea of a solution or outcome i.e., the claim fails to recite details of how a solution to a problem is accomplished. The recitation of claim limitations that attempt to cover any solution to an identified problem with no restriction on how the result is accomplished and no description of the mechanism for accomplishing the result, does not integrate a judicial exception into a practical application or provide significantly more because this type of recitation is equivalent to the words "apply it".
Claim 38
Dependent claim 38 recites “wherein running the osteotomy simulation includes generating a pedicle assembly that attaches the fixation rod to the spinal column”. This limitation is viewed as merely reciting the words “apply it” or an equivalent, where the generating of a pedicle assembly is based on the data inputted into the computer system, see MPEP 2106.05(f) “(3) The particularity or generality of the application of the judicial exception. A claim having broad applicability across many fields of endeavor may not provide meaningful limitations that integrate a judicial exception into a practical application or amount to significantly more. For instance, a claim that generically recites an effect of the judicial exception or claims every mode of accomplishing that effect, amounts to a claim that is merely adding the words "apply it" to the judicial exception.”.
Dependent claim 38 recites “and determining a location of the pedicle assembly along the fixation rod and the spinal column based on the predicted loading in the fixation rod along the morphology at the pedicle assembly, or based on the predicted loading from the fixation rod to the morphology through the pedicle assembly”. This limitation amounts to mere instructions to apply an exception, where it recites an idea of a solution. See MPEP 2106.05 (f) (1) Whether the claim recites only the idea of a solution or outcome i.e., the claim fails to recite details of how a solution to a problem is accomplished. The recitation of claim limitations that attempt to cover any solution to an identified problem with no restriction on how the result is accomplished and no description of the mechanism for accomplishing the result, does not integrate a judicial exception into a practical application or provide significantly more because this type of recitation is equivalent to the words "apply it".
Dependent claim 38 recites “and the method further comprises implanting the fixation rod and the pedicle assembly in the patient”. This limitation is viewed as merely reciting the words “apply it” or an equivalent, where the implanting of the fixation rod and pedicle is based on the simulation, see MPEP 2106.05(f) “(3) The particularity or generality of the application of the judicial exception. A claim having broad applicability across many fields of endeavor may not provide meaningful limitations that integrate a judicial exception into a practical application or amount to significantly more. For instance, a claim that generically recites an effect of the judicial exception or claims every mode of accomplishing that effect, amounts to a claim that is merely adding the words "apply it" to the judicial exception.”.
Dependent claim 38 recites “wherein the pedicle assembly is attached to the fixation rod and the patient at the determined locations.”. Under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
Claim 39
Dependent claim 39 recites “determining a morphotype of the patient based on the inputted data”. This limitation amounts to mere instructions to apply an exception, where it recites an idea of a solution. The limitation doesn’t indicate how the morphotype of the patient is being determined. See MPEP 2106.05 (f) (1) Whether the claim recites only the idea of a solution or outcome i.e., the claim fails to recite details of how a solution to a problem is accomplished. The recitation of claim limitations that attempt to cover any solution to an identified problem with no restriction on how the result is accomplished and no description of the mechanism for accomplishing the result, does not integrate a judicial exception into a practical application or provide significantly more because this type of recitation is equivalent to the words "apply it".
Dependent claim 39 recites “inputting fixation rod morphologies from post operative results into the computer system”. This limitation amounts to insignificant extra-solution activity of receiving data i.e. pre-solution activity of gathering data for use in the claimed process, see MPEP 2106.05(g).
Dependent claim 39 recites “and determining the fixation rod morphotype includes matching the morphotype of the patient to the fixation rod morphologies”. Under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
Claim 40
Dependent claim 40 recites “wherein matching the morphotype of the patient to the fixation rod morphologies includes storing the morphologies as a condensed distillation, separating the condensed distillation into sets”. This limitation amounts to insignificant extra-solution activity of receiving data i.e. pre-solution activity of gathering data for use in the claimed process, see MPEP 2106.05(g).
Dependent claim 40 recites “determining one or more fixation rod morphotypes including curves based on the sets, and matching the morphotype of the patient to one or more of the curves of the fixation rod morphotypes.”. Under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
Claim 41
Dependent claim 41 recites “wherein the patient data includes bone quality at the morphology”. Under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
Dependent claim 41 recites “and performing the osteotomy simulation includes determining the loading from the fixation rod to the morphology, and includes matching the bone quality to the one or more of the fixation rod morphotypes”. This limitation amounts to mere instructions to apply an exception, where it recites an idea of a solution. The limitation doesn’t indicate how the loading from the fixation rod to the morphology is being conducted. See MPEP 2106.05 (f) (1) Whether the claim recites only the idea of a solution or outcome i.e., the claim fails to recite details of how a solution to a problem is accomplished. The recitation of claim limitations that attempt to cover any solution to an identified problem with no restriction on how the result is accomplished and no description of the mechanism for accomplishing the result, does not integrate a judicial exception into a practical application or provide significantly more because this type of recitation is equivalent to the words "apply it".
Claim 42
Dependent claim 42 recites “inputting fixation rod morphologies and corresponding post operative data into the computer system”. This limitation amounts to insignificant extra-solution activity of receiving data i.e. pre-solution activity of gathering data for use in the claimed process, see MPEP 2106.05(g).
Dependent claim 42 recites “wherein performing the osteotomy simulation includes: generating the at least one shape and curvature by determining a length of a transition region of the fixation rod based on the predicted loading in the fixation rod or the predicted loading from the fixation rod to the morphology of the patient”. This limitation doesn’t distinguish itself from being able to be conducted in the human mind or with pencil and paper. Therefore, under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
Dependent claim 42 recites “wherein the transition region is positioned at the junction and has a diameter that gradually tapers between adjacent sections of the fixation rod, and the adjacent sections have different diameters”. Under the broadest reasonable interpretation, this limitation is a process step that covers performance in the human mind or with the aid of pencil and paper. As such, this limitation falls within the “Mental Process” grouping of abstract ideas.
Claims 1-7 and 30-42 are therefore not drawn to eligible subject matter as they are directed to an abstract idea without significantly more.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness
rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35
U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 6, 35-36, and 39-40 is/are rejected under 35 U.S.C. 103 as being unpatentable
over online reference With AI, 3D imaging and a robot, Medtronic Spine aims to leave competitors bent out of shape, written by Parmar in view of Ballard et al. (U.S. PGPub 2014/0316420) in further view of online reference Vertebral column decancellation in Pott’s deformity: use of Surgimap Spine for preoperative surgical planning, retrospective review of 18 patients, written by Hu et al.
With respect to claim 1, Parmar discloses “A method” as [Parmar (Pg. 6, last paragraph, “This product makes us the first company to offer an integrated solution with AI-driven planning, personalized implants and robotic-assisted surgery,” he noted”, Having an AI-driven plan to conduct the surgery, demonstrates that there’s a method, since a method is a systematic procedure, technique, or mode of inquiry employed by or proper to a particular discipline or art, see attachment of definition of a method)];
“wherein the computer system comprises an artificial intelligence program” as [Parmar (Pg. 3, 1st paragraph “The French startup provides AI-driven surgical planning and predictive modeling tools that helps to create personalized implants that in turn provides a better surgeon experience and more importantly, improved surgical outcomes for patients.”, Parmar (Pg. 6, 4th paragraph “Currently, the AI engine can be tapped from Medicrea even without the surgeon opting to use the Mazor robot, Paul said. But in the next year or so, the plan is to integrate the robot with Medicrea’s AI system.”)];
“including generating a morphology of the patient based on the inputted data” as [Parmar (Pg. 4, 1st paragraph, “Any patient undergoing complex spinal surgery will have medical imaging generally, CT scans done to understand how to correct for abnormalities/deformities in the spine. These images help the surgeons to decide how to align the spine correctly and what is the curvature needed in the rod to give the patient a better quality of life. How good that decision depends on a surgeon’s experience.”
“generating at least one shape and curvature of a fixation rod that is fixed with and mimics a morphology of the patient” as [Parmar (Pg. 3, 2nd paragraph “Medtronic’s goal is to create the “augmented surgeon” with the help of surgical navigation, robotics and artificial intelligence”, Parmar Pg. 5, 3rd paragraph “Here Medicrea is able to provide a level of customization that is relatively new to the world of spinal surgery that has in the past worked with off-the-shelf implants. Based on a surgeon’s decision, Medicrea is able to use 3-D printing to manufacture the spinal rod and pre-bend based on the parameters already selected by surgeon and then have it shipped for final surgery.”)];
“predicting loading including at least one of a loading in the fixation rod and a loading from the fixation rod to the morphology, and determining a fixation rod morphotype from the at least one shape and curvature, the fixation rod morphotype including at least one diameter based on the predicted loading” as [Parmar (Pg. 3, 1st paragraph, “The French startup provides AI-driven surgical planning and predictive modeling tools that helps to create personalized implants that in turn provides a better surgeon experience and more importantly, improved surgical outcomes for patients.”, The examiner considers the surgical planning and predictive modeling tools that helps to create personalized implants to be the loading in the fixation rod, since it helps the surgeon decide how to align the spine correctly. Also, the examiner considers the personalized implants that are created to be the fixation rod, since the implants are used to help correct the spine of a patient)];
“preoperatively machining the fixation rod including the fixation rod morphotype, and then intraoperatively bending the fixation rod to the at least one shape and curvature” as [Parmar (Pg. 5, 3rd paragraph “Here Medicrea is able to provide a level of customization that is relatively new to the world of spinal surgery that has in the past worked with off-the-shelf implants. Based on a surgeon’s decision, Medicrea is able to use 3-D printing to manufacture the spinal rod and pre-bend based on the parameters already selected by surgeon and then have it shipped for final surgery.”)];
While Parmar teaches using an AI-driven plan and predictive modeling tools for spinal surgery and generating a custom multi-diameter fixation rod, Parmar doesn’t explicitly disclose “inputting into a computer system, wherein the computer system comprises a processor, a non-transitory memory, data from pre-surgical measurements of spinal curvature of a patient”
Ballard et al. discloses “inputting into a computer system, wherein the computer system comprises a processor, a non-transitory memory, data from pre-surgical measurements of spinal curvature of a patient” as [Ballard et al. (paragraph [0030] “In one embodiment, the system for measuring a surgical rod 10 includes a processor 11 for receiving positional and rotational data representative of movement of a probe 15 along a surgical rod 21. The data can be stored in a memory 13 in communication with the processor 11.”, Ballard et al. paragraph [0041] “As a general rule, after making the decision to implant a fixation system into a patient, a surgeon will take a plurality of spinal measurements of the patient and determine the precise geometries required for the spinal rod. That is, the surgeon determines a number of bends and angles of the bends to the rod required in the sagittal, coronal and/or transverse planes. These predetermined/preoperative measurements are brought into the operating room where the rod 21 is initially bent on a back table 20 prior to being positioned within the patient 40. The preoperative measurements can also be input into the measuring system 10 and stored in memory 13 for later use in confirming the proper bending of the rod 21, as will be described below.”)];
Parmar and Ballard et al. are analogous art because they are from the same field endeavor of analyzing a spinal rod for spinal surgery.
Before the effective filing date of the invention, it would have been obvious to a person of ordinary skill in the art to modify the teachings of Parmar et al. of using an AI-driven plan and predictive modeling tools for spinal surgery and generating a custom multi-diameter fixation rod by incorporating inputting into a computer system, wherein the computer system comprises a processor, a non-transitory memory, data from pre-surgical measurements of spinal curvature of a patient as taught by Ballard et al. for the purpose of determining geometries of a surgical rod to provide stabilization of a vertebrae.
Parmar in view of Ballard et al. teaches inputting into a computer system, wherein the computer system comprises a processor, a non-transitory memory, data from pre-surgical measurements of spinal curvature of a patient.
The motivation for doing so would have been because Ballard et al. teaches that moving a probe along the surface of an implant (rod) prior to positioning the implant within a patient, the ability to adjust the shape of the rod before attaching the rod to the segment of the vertebrae can be accomplished, so that the surgeon can know the correct placement of the rod before starting the surgical procedure (Ballard et al. (paragraph [0004] — [0006])).
While the combination of Parmar and Ballard et al. teaches determining at least one shape and curvature that mimics a patient's morphology utilizing artificial intelligence and generating a custom multi-diameter fixation rod, Parmar and Ballard et al. do not explicitly disclose “running an osteotomy simulation with the computer system based on the inputted data”
Hu et al. discloses “running an osteotomy simulation with the computer system based on the inputted data” as [Hu et al. (Pg. 2, right col., last paragraph “Anteroposterior and lateral spine radiographs, 3-dimensional computed tomography (3-D CT) reconstruction, and magnetic resonance imaging (MRI), etc.”, Hu et al. Pg. 8, left col., “In the current study, Surgimap was used to measure pre-and postoperative spinal parameters and to simulate an osteotomy procedure.”, Fig. 2)];
Parmar, Ballard et al. and Hu et al. are analogous art because they are from the same field endeavor of analyzing surgical planning for spinal surgery.
Before the effective filing date of the invention, it would have been obvious to a person of ordinary skill in the art to modify the teachings of Parmar et al. and Ballard et al. of determining at least one shape and curvature that mimics a patient's morphology utilizing artificial intelligence and generating a custom multi-diameter fixation rod by incorporating running an osteotomy simulation with the computer system based on the inputted data as taught by Hu et al. for the purpose of evaluating the efficacy of Vertebral column decancellation planned preoperatively.
Parmar in view of Ballard et al. in further view of Hu et al. teaches running an osteotomy simulation with the computer system based on the inputted data.
The motivation for doing so would have been because Hu et al. teaches that by evaluating the efficacy of Vertebral column decancellation planned preoperatively the ability to determine if the Vertebral column decancellation is an effective treatment option for severe Pott’s kyphosis (Hu et al. Pg. 1, Conclusion, “Vertebral column decancellation is an effective treatment option for severe Pott’s kyphosis.”).
With respect to claim 6, the combination of Parmar, Ballard et al. and Hu et al. discloses the method of claim 1 above, and Ballard et al. further discloses “wherein the at least one shape and curvature of the fixation rod comprises a plurality of sections that each comprise different diameters, and each of the different diameters is constant along a longitudinal axis of the fixation rod” as [Ballard et al. (paragraph [0041] “That is, the surgeon determines a number of bends and angles of the bends to the rod required in the sagittal, coronal and/or transverse planes. These predetermined/preoperative measurements are brought into the operating room where the rod 21 is initially bent on a back table 20 prior to being positioned within the patient 40……The surgeon 18 can again adjust the bends in the rod 21. The surgeon 18 then tightens the set screws 42 onto the rod 21 to secure the rod 21 in the fasteners (e.g., bone screws) 41.”)];
Paramar discloses “wherein the at least one shape and curvature of the fixation rod comprises a plurality of sections that each comprise different diameters determined based on the predicted loading” as [Parmar (Pg. 3, 1st paragraph “The French startup provides AI-driven surgical planning and predictive modeling tools that helps to create personalized implants that in turn provides a better surgeon experience and more importantly, improved surgical outcomes for patients.”)];
With respect to claim 35, the combination of Parmar, Ballard et al. and Hu et al. discloses the method of claim 1 above, and Parmar further discloses “determining a custom shape of the fixation rod for the patient as the at least one shape and curvature” as [Parmar (Pg. 3, 1st paragraph, “The French startup provides AI-driven surgical planning and predictive modeling tools that helps to create personalized implants that in turn provides a better surgeon experience and more importantly, improved surgical outcomes for patients.”)];
“or adding a curve or a tapered segment to the fixation rod” as [Parmar (Pg. 5, 3rd paragraph “Here Medicrea is able to provide a level of customization that is relatively new to the world of spinal surgery that has in the past worked with off-the-shelf implants. Based on a surgeon’s decision, Medicrea is able to use 3-D printing to manufacture the spinal rod and pre-bend based on the parameters already selected by surgeon and then have it shipped for final surgery.”)];
Ballard et al. discloses “and implanting the fixation rod, including intraoperatively modifying the fixation rod from the determined fixation rod morphotype to the custom shape by sizing the fixation rod down with a desired taper or curvature, turning the fixation rod” as [Ballard et al. paragraph [0041] “As a general rule, after making the decision to implant a fixation system into a patient, a surgeon will take a plurality of spinal measurements of the patient and determine the precise geometries required for the spinal rod. That is, the surgeon determines a number of bends and angles of the bends to the rod required in the sagittal, coronal and/or transverse planes. These predetermined/preoperative measurements are brought into the operating room where the rod 21 is initially bent on a back table 20 prior to being positioned within the patient 40.”)];
With respect to claim 36, the combination of Parmar, Ballard et al. and Hu et al. discloses the method of claim 1 above, and Ballard et al. further discloses “implanting the fixation rod, including augmenting a flex of the fixation rod to the morphology of the patient by on site intraoperative modification adding a curve to the fixation rod along a longitudinal axis of the fixation rod.”. as [Ballard et al. paragraph [0041] “As a general rule, after making the decision to implant a fixation system into a patient, a surgeon will take a plurality of spinal measurements of the patient and determine the precise geometries required for the spinal rod. That is, the surgeon determines a number of bends and angles of the bends to the rod required in the sagittal, coronal and/or transverse planes. These predetermined/preoperative measurements are brought into the operating room where the rod 21 is initially bent on a back table 20 prior to being positioned within the patient 40.”)];
With respect to claim 39, the combination of Parmar, Ballard et al. and Hu et al. discloses the method of claim 1 above, and Ballard et al. further discloses “determining a morphotype of the patient based on the inputted data” as [Ballard et al. (paragraph [0041] “As a general rule, after making the decision to implant a fixation system into a patient, a surgeon will take a plurality of spinal measurements of the patient and determine the precise geometries required for the spinal rod. That is, the surgeon determines a number of bends and angles of the bends to the rod required in the sagittal, coronal and/or transverse planes. These predetermined/preoperative measurements are brought into the operating room where the rod 21 is initially bent on a back table 20 prior to being positioned within the patient 40. The preoperative measurements can also be input into the measuring system 10 and stored in memory 13 for later use in confirming the proper bending of the rod 21”)];
“inputting fixation rod morphologies from post operative results into the computer system, and determining the fixation rod morphotype includes matching the morphotype of the patient to the fixation rod morphologies” as [Ballard et al. (paragraph [0041] “The preoperative measurements can also be input into the measuring system 10 and stored in memory 13 for later use in confirming the proper bending of the rod 21”)];
With respect to claim 40, the combination of Parmar, Ballard et al. and Hu et al. discloses the method of claim 1 above, and Ballard et al. further discloses “wherein matching the morphotype of the patient to the fixation rod morphologies includes storing the morphologies as a condensed distillation, separating the condensed distillation into sets”. as [Ballard et al. (paragraph [0041] “As a general rule, after making the decision to implant a fixation system into a patient, a surgeon will take a plurality of spinal measurements of the patient and determine the precise geometries required for the spinal rod. That is, the surgeon determines a number of bends and angles of the bends to the rod required in the sagittal, coronal and/or transverse planes. These predetermined/preoperative measurements are brought into the operating room where the rod 21 is initially bent on a back table 20 prior to being positioned within the patient 40. The preoperative measurements can also be input into the measuring system 10 and stored in memory 13 for later use in confirming the proper bending of the rod 21, as will be described below……The surgeon 18 then tightens the set screws 42 onto the rod 21 to secure the rod 21 in the fasteners (e.g., bone screws) 41.”, Ballard et al. paragraph [0045] “Once the rod 21 is seated in the fasteners 41, set screws 42 can be installed. Tightening of the set screws 42 may occur at this time or additional bending of the rod 21 can occur before the set screws 42 undergo a final tightening onto rod 21.”)];
“determining one or more fixation rod morphotypes including curves based on the sets, and matching the morphotype of the patient to one or more of the curves of the fixation rod morphotypes” as [Ballard et al. (paragraph [0041] “As a general rule, after making the decision to implant a fixation system into a patient, a surgeon will take a plurality of spinal measurements of the patient and determine the precise geometries required for the spinal rod. That is, the surgeon determines a number of bends and angles of the bends to the rod required in the sagittal, coronal and/or transverse planes. These predetermined/preoperative measurements are brought into the operating room where the rod 21 is initially bent on a back table 20 prior to being positioned within the patient 40. The preoperative measurements can also be input into the measuring system 10 and stored in memory 13 for later use in confirming the proper bending of the rod 21, as will be described below……The surgeon 18 then tightens the set screws 42 onto the rod 21 to secure the rod 21 in the fasteners (e.g., bone screws) 41.”, Ballard et al. paragraph [0045] “Once the rod 21 is seated in the fasteners 41, set screws 42 can be installed. Tightening of the set screws 42 may occur at this time or additional bending of the rod 21 can occur before the set screws 42 undergo a final tightening onto rod 21.”)];
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable Parmar in view of
Ballard et al. in further view of o Hu et al. in further view of Hillard (U.S. Patent 443,764).
With respect to claim 2, the combination of Parmar, Ballard et al. and Hu et al. discloses
the method of claim 1 above, and Hu et al. further discloses “implanting the fixation rod” as Hu et al. (Pg. 5, left col., 1st paragraph “After removing the posterior cortical bone of the osteotomized vertebra, the kyphotic spine was corrected using gentle manual force, and was stabilized with a temporary rod.”
Ballard et al. discloses “and the at least one shape and curvature is positioned above or below a thoracolumbar junction or cervical thoracic junction in the patient morphology” as [Ballard (paragraph [0024] “The present disclosure may also be alternatively employed with procedures for treating the lumbar, cervical, thoracic, sacral and pelvic regions of a spinal column.”, Ballard et al. paragraph [0035] “For example, the detector 12 may also be able to detect other probes (not shown), or detect a location of a rod equipped with a tracking element”, Ballard et al. paragraph [0036] “Alternatively, the rod may be held in front of the tracking system in at least one view whereby the tracking system will "see" the rod and store the location of the rod and display it on the screen.”)];
While Parmar, Ballard et al. and Hu et al. teaches generating a custom multi-diameter
fixation rod, Parmar, Ballard et al. and Hu et al. do not explicitly disclose “wherein the at least
one shape and curvature of the fixation rod is a single rod that is monolithically formed and runs along the morphology of the patient including a spinal column in a direction from an occiput toward a sacrum in the patient”
Hillard discloses “wherein the at least one shape and curvature of the fixation rod is a single rod that is monolithically formed and runs along the morphology of the patient including a spinal column in a direction from an occiput toward a sacrum in the patient” as [Hillard (Pg. 2, left col., lines 37-40 “The spinal extension is applied in the direct line of the spinal column between the head H and the sacrum S to correct the spinal curvature in the following manner:”, Hillard Pg. 2, right col., lines 79-91 “the head may be fixed by a buckle-band 1im around the forehead, proceeding from two fixed arms 1h", extending front the top of the rod h at the occiput-padt h', as shown in the modification, Figs. 3 and 4, thus dispensing with the sliding arm iand strap j under the chin, as in Figs. 1 and 2. When the head is 85 thus fixed, the nut g2 at the lower end of the rod hz, over the spring g' and sockets g g" at the sacrum S, is slowly turned, and as it descends on the rod the spring g', acting upon the lower side of the nut g2n, pushes up the 90 rod or mast h until the requisite extension of the spine is arrived at.”, Figs. 3 and 4)];
Parmar, Ballard et al., Hu et al. and Hillard are analogous art because they are from the same field endeavor of analyzing surgical planning for spinal surgery.
Before the effective filing date of the invention, it would have been obvious to a person
of ordinary skill in the art to modify the teachings of Parmar et al., Ballard et al. and Hu et al. of
generating a custom multi-diameter fixation rod by incorporating wherein the at least
one shape and curvature of the fixation rod is a single rod that is monolithically formed and runs along the morphology of the patient including a spinal column in a direction from an occiput toward a sacrum in the patient as taught by Hillard for the purpose of improving appliances for applying extension to the spinal column of children and persons or animals.
Parmar in view of Ballard et al. in further view of Hu et al. in further view of Hillard
teaches wherein the at least one shape and curvature of the fixation rod is a single rod that is monolithically formed and runs along the morphology of the patient including a spinal column in a direction from an occiput toward a sacrum in the patient.
The motivation for doing so would have been because Hillard teaches that by improving appliances for applying extension to the spinal column of children and persons or animals, there’s no binding or restricting of the chest or abdomen, which gives a more comfortable and resilient effect and feeling to the patient with greater power of movement (Hillard (Pg. 2 liens 12-26, “My said invention has reference, etc.”).
Claim(s) 3-5 is/are rejected under 35 U.S.C. 103 as being unpatentable Parmar
in view of Ballard et al. in further view of o Hu et al. in further view of Hillard in further view of online reference SpineShape The dynamic solution for your back Technical information to System IV, written by SpineShape
With respect to claim 3, the combination of Parmar, Ballard et al., Hu et al. Hillard discloses the method of claim 2 above, and Parmar further discloses “and running the osteotomy simulation also includes performing the at least one determination includes determining a variable bending stiffness or a flex of the fixation rod along the morphology based on a local diameter of each of the sections” as [Parmar (Pg. 3, 1st paragraph “The French startup provides AI-driven surgical planning and predictive modeling tools that helps to create personalized implants that in turn provides a better surgeon experience and more importantly, improved surgical outcomes for patients.”, Parmar (Pgs. 4-5, last paragraph “It is here that Medicrea’s AI engine can be more precise. The company has developed a repository of 6,000 3-D images based on which the AI engine can, etc.”)];
While the combination of Parmar, Ballard et al., Hu et al. Hillard teaches a fixation rod is a single rod that runs from occiput to sacrum, Parmar, Ballard et al., Hu et al. Hillard do not explicitly disclose “wherein the at least one shape and curvature of the fixation rod comprises a plurality of sections, the plurality of sections each comprise different diameters.”
SpineShape disclose “wherein the at least one shape and curvature of the fixation rod comprises a plurality of sections, the plurality of sections each comprise different diameters.” as [SpineShape (Pg. 3, left summary “The stepped region of the Varistab, etc.”, SpineShape Pg. 4, Roos Flexibility (mid-flex and low-flex) Type (stepped (Varistab), The examiner considers the stepped regions to be the different diameters of the plurality of sections, since the stepped regions are located at different points of the spinal rod that are attached to the patient, where the spinal rod has a different diameter)];
Parmar, Ballard et al., Hu et al., Hillard and SpineShape are analogous art because they are from the same field endeavor of analyzing surgical planning for spinal surgery.
Before the effective filing date of the invention, it would have been obvious to a person of ordinary skill in the art to modify the teachings of Parmar et al., Ballard et al., Hu et al. and Hillard of having a fixation rod is a single rod that runs from occiput to sacrum by incorporating wherein the at least one shape and curvature of the fixation rod comprises a plurality of sections, the plurality of sections each comprise different diameters as taught by SpineShape for the purpose of stabilizing the lumbar vertebrae and intervertebral discs through flexible rods.
Parmar in view of Ballard et al. in further view of Hu et al. in further view of Hillard in further view of SpineShape teaches wherein the at least one shape and curvature of the fixation rod comprises a plurality of sections, the plurality of sections each comprise different diameters.
The motivation for doing so would have been because SpineShape teaches that by stabilizing the lumbar vertebrae and intervertebral discs through flexible rods, the ability to preserve the lower spine can be accomplished, which results in long-lasting pain relief (SpineShape, Pg. 2 SpineShape System IV highlights).
With respect to claim 4, the combination of Parmar, Ballard et al., Hu et al., Hillard and SpineShape discloses the method of claim 3 above, and SpineShape further discloses “wherein the at least one shape and curvature of the fixation rod comprises transition region positioned between the plurality of sections, the transition region gradually varies in diameter between the plurality of sections along a longitudinal axis of the fixation rod” as [SpineShape (Pg. 3, left summary “The stepped region of the Varistab, etc.”, SpineShape Pg. 4, Roos Flexibility (mid-flex and low-flex) Type (stepped (Varistab), The examiner considers the stepped regions to be the different diameters of the plurality of sections, since the stepped regions are located at different points of the spinal rod that are attached to the patient, where the spinal rod has a different diameter)];
Paramar discloses “the transition region gradually varies in diameter based on the osteotomy simulation between the plurality of sections along a longitudinal axis of the fixation rod” as [Parmar (Pg. 3, 1st paragraph “The French startup provides AI-driven surgical planning and predictive modeling tools that helps to create personalized implants that in turn provides a better surgeon experience and more importantly, improved surgical outcomes for patients.”, The examiner considers the personalized implants to be the fixation rod that varies in the transition region, since the personalized implant helps improves the surgical outcomes for the patients)];
“running the osteotomy simulation includes predicting the variable bending stiffness or the flex of the fixation rod along the morphology at the transition region based on the diameter of the fixation rod morphotype along the transition region” as [Parmar (Pg. 3, 1st paragraph “The French startup provides AI-driven surgical planning and predictive modeling tools that helps to create personalized implants that in turn provides a better surgeon experience and more importantly, improved surgical outcomes for patients.”)];
With respect to claim 5, the combination of Parmar, Ballard et al., Hu et al., Hillard and SpineShape discloses the method of claim 4 above, and Parmar further discloses “generating fixation devices in the osteotomy simulation” as [Parmar (Pg. 3, 1st paragraph “The French startup provides AI-driven surgical planning and predictive modeling tools that helps to create personalized implants that in turn provides a better surgeon experience and more importantly, improved surgical outcomes for patients.”)];
“wherein running the osteotomy simulation includes predicting at least one of the loading in the fixation rod between the fixation devices, and the loading from the fixation rod to the morphology through the fixation devices at predetermined locations” as [Parmar (Pg. 3, 1st paragraph “The French startup provides AI-driven surgical planning and predictive modeling tools that helps to create personalized implants that in turn provides a better surgeon experience and more importantly, improved surgical outcomes for patients.”, Parmar (Pgs. 4-5, last paragraph “It is here that Medicrea’s AI engine can be more precise. The company has developed a repository of 6,000 3-D images based on which the AI engine can, etc.”)];
“and physically forming the fixation devices generated in the osteotomy simulation, and then implanting the fixation rod and the fixation devices” as [Parmar (Pg. 5, 3rd paragraph “Here Medicrea is able to provide a level of customization that is relatively new to the world of spinal surgery that has in the past worked with off-the-shelf implants. Based on a surgeon’s decision, Medicrea is able to use 3-D printing to manufacture the spinal rod and pre-bend based on the parameters already selected by surgeon and then have it shipped for final surgery.”)];
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable Parmar in
view of Ballard et al. in further view of o Hu et al. in further view online reference SpineShape The dynamic solution for your back Technical information to System IV, written by SpineShape.
With respect to claim 7, the combination of Parmar, Ballard et al. and Hu et al. discloses the method of claim 6 above, and Parmar further discloses “and determining the fixation rod morphotype in the osteotomy simulation includes calculating the Bezier curve.” as [Parmar (Pg. 4, 1st paragraph, “Any patient undergoing complex spinal surgery will have medical imaging generally, CT scans done to understand how to correct for abnormalities/deformities in the spine. These images help the surgeons to decide how to align the spine correctly and what is the curvature needed in the rod to give the patient a better quality of life.”, The examiner considers the curvature in the rod to be the Bezier curve, since the curvature of the rod has points along the rod that are to connect to the patient’s spine)];
While the combination of Parmar, Ballard et al. and Hu et al. teaches a fixation rod is a single rod that runs from occiput to sacrum, Parmar, Ballard et al. and Hu et al. do not explicitly disclose “wherein the at least one shape and curvature of the fixation rod comprises a plurality of transition regions positioned between the plurality of sections; and wherein of each transition extends region along a longitudinal axis of the fixation rod is defined by a Bezier curve”
SpineShape further discloses “wherein the at least one shape and curvature of the fixation rod comprises a plurality of transition regions positioned between the plurality of sections”. as [SpineShape (Pg. 3, left summary “The stepped region of the Varistab, etc.”, SpineShape Pg. 4, Roos Flexibility (mid-flex and low-flex) Type (stepped (Varistab), The examiner considers the stepped regions to be the different diameters of the plurality of sections, since the stepped regions are located at different points of the spinal rod that are attached to the patient, where the spinal rod has a different diameter)];
“and wherein of each transition extends region along a longitudinal axis of the fixation rod is defined by a Bezier curve” as [SpineShape (Pg. 3, left summary “The stepped region of the Varistab, etc.”, The figure shown on Pg. 3 of the SpineShape reference, shows the spinal rod have a curve. The examiner considers the curve in the spinal rod to be a Bezier curve since it has points along the rod that are to connect to the patient’s spine)];
Parmar, Ballard et al., Hu et al. and SpineShape are analogous art because they are from the same field endeavor of analyzing surgical planning for spinal surgery.
Before the effective filing date of the invention, it would have been obvious to a person of ordinary skill in the art to modify the teachings of Parmar et al., Ballard et al. and Hu et al. of having a fixation rod is a single rod that runs from occiput to sacrum by incorporating wherein the at least one shape and curvature of the fixation rod comprises a plurality of transition regions positioned between the plurality of sections; and wherein of each transition extends region along a longitudinal axis of the fixation rod is defined by a Bezier curve as taught by SpineShape for the purpose of stabilizing the lumbar vertebrae and intervertebral discs through flexible rods.
Parmar in view of Ballard et al. in further view of Hu et al. in further view of SpineShape teaches wherein the at least one shape and curvature of the fixation rod comprises a plurality of transition regions positioned between the plurality of sections; and wherein of each transition extends region along a longitudinal axis of the fixation rod is defined by a Bezier curve.
The motivation for doing so would have been because SpineShape teaches that by stabilizing the lumbar vertebrae and intervertebral discs through flexible rods, the ability to preserve the lower spine can be accomplished, which results in long-lasting pain relief (SpineShape, Pg. 2 SpineShape System IV highlights).
Claim(s) 30-34 is/are rejected under 35 U.S.C. 103 as being unpatentable Parmar
in view of Ballard et al. in further view of o Hu et al. in further view of Hillard in further view of SpineShape in further view of Steinberg et al. (CA 3116288).
With respect to claim 30, the combination of Parmar, Ballard et al., Hu et al., Hillard and SpineShape discloses the method of claim 4 above.
While the combination of Parmar, Ballard et al., Hu et al., Hillard and SpineShape
teaches varying the diameter of the fixation rod, Parmar, Ballard et al., Hu et al., Hillard and SpineShape do not explicitly disclose “wherein the transition region is tapered along the longitudinal direction of the fixation rod from a first diameter at a first section of the plurality of sections to a second diameter at a second section of the plurality of sections; performing the osteotomy simulation includes predicting the loading using an algorithm to calculate the diameter of the transition region from the first diameter to the second diameter based on the pre-surgical measurements and the fixation rod; generating the at least one shape and curvature includes determining the first diameter, the second diameter, or a length of the transition region based on the predicted loading.”
Steinberg et al. discloses “wherein the transition region is tapered along the longitudinal direction of the fixation rod from a first diameter at a first section of the plurality of sections to a second diameter at a second section of the plurality of sections” as [Steinberg et al. (Pg. 6, 1st paragraph, “Based on the finite element analysis and assessment of implant stability, optimal implant characteristics are selected, including at least some of length and diameter, material and composition, curvature or shape, position and orientation in relationship to the vertebra height, depth and angle.”)];
“performing the osteotomy simulation includes predicting the loading using an algorithm to calculate the diameter of the transition region from the first diameter to the second diameter based on the pre-surgical measurements and the fixation rod”. as [Steinberg et al. (Pg. 4, 2nd paragraph “For a given patient, the preoperative analysis including
Finite element analysis and statistical predictions of future patient health status scenarios, will
be incorporated into the prediction algorithm. The rod or rods to be implanted are selected and contoured according to the experience of the surgeon or other medical practitioner performing the procedure, or in coordination with a machine generated plan, to provide an adequate solution to the patient's pathology, and to have resulting stress scores along the entire length of the bone-implant system, that fall within the predetermined acceptable range.”, Steinberg et al. Pg. 6, 1st paragraph, “Based on the finite element analysis and assessment of implant stability, optimal implant characteristics are selected, including at least some of length and diameter, material and composition, curvature or shape, position and orientation in relationship to the vertebra height, depth and angle.”)];
“generating the at least one shape and curvature includes determining the first diameter, the second diameter, or a length of the transition region based on the predicted loading.” as [Steinberg et al. (Pg. 5, last paragraph “A computerized assessment using finite element analysis, which indicates the stress distribution along the implant and the ensuing strains, is then carried out to determine the likely success of each bone-implant system under various levels of mechanical stress.”, Steinberg et al. (Pg. 6, 1st paragraph, “Based on the finite element analysis and assessment of implant stability, optimal implant characteristics are selected, including at least some of length and diameter, material and composition, curvature or shape, position and orientation in relationship to the vertebra height, depth and angle.”)];
Parmar, Ballard et al., Hu et al., Hillard, SpineShape and Steinberg et al. are analogous art because they are from the same field endeavor of analyzing surgical planning for spinal surgery.
Before the effective filing date of the invention, it would have been obvious to a person
of ordinary skill in the art to modify the teachings of Parmar, Ballard et al., Hu et al., Hillard and SpineShape varying the diameter of the fixation rod of by incorporating wherein the transition region is tapered along the longitudinal direction of the fixation rod from a first diameter at a first section of the plurality of sections to a second diameter at a second section of the plurality of sections; performing the osteotomy simulation includes predicting the loading using an algorithm to calculate the diameter of the transition region from the first diameter to the second diameter based on the pre-surgical measurements and the fixation rod; generating the at least one shape and curvature includes determining the first diameter, the second diameter, or a length of the transition region based on the predicted loading as taught by Steinberg et al. for the purpose of predicting the level of force on an implant for a patient.
Parmar in view of Ballard et al. in further view of Hu et al. in further view of Hillard in further view of SpineShape in further view of Steinberg et al. teaches wherein the transition region is tapered along the longitudinal direction of the fixation rod from a first diameter at a first section of the plurality of sections to a second diameter at a second section of the plurality of sections; performing the osteotomy simulation includes predicting the loading using an algorithm to calculate the diameter of the transition region from the first diameter to the second diameter based on the pre-surgical measurements and the fixation rod; generating the at least one shape and curvature includes determining the first diameter, the second diameter, or a length of the transition region based on the predicted loading.
The motivation for doing so would have been because Steinberg et al. teaches that by predicting the level of force on an implant for a patient, the ability to have a favorable long-term surgical outcomes and long-term bone-implant survival can be accomplished. This procedure would make it easier for a surgeon to correct a spine for a patient (Steinberg et al. Pg. 3, Summary, 1st – 2nd paragraph, “There exist a need for a method, etc.”).
With respect to claim 31, the combination of Parmar, Ballard et al., Hu et al., Hillard, SpineShape and Steinberg et al. discloses the method of claim 30 above, Parmar further discloses “wherein running the osteotomy simulation includes generating fixation devices that attach the fixation rod to the morphology of the patient” as [Parmar (Pg. 3, 1st paragraph “The French startup provides AI-driven surgical planning and predictive modeling tools that helps to create personalized implants that in turn provides a better surgeon experience and more importantly, improved surgical outcomes for patients.”)];
Steinberg et al. discloses “then predicting the loading in the fixation rod between the fixation devices along the morphology, or predicting the loading from the fixation rod to the morphology through the fixation devices” as [Steinberg et al. (Pg. 5, last paragraph “A computerized assessment using finite element analysis, which indicates the stress distribution along the implant and the ensuing strains, is then carried out to determine the likely success of each bone-implant system under various levels of mechanical stress.”)];
“and determining a location of the fixation devices relative to the fixation rod and the morphology of the patient based on the predicted loading” as [Steinberg et al. (Pg. 4, 1st paragraph “These stress scores indicate the level of post-operative stress likely to be placed on each individual rod component of the entire implant system at each point along its extent. The regions of contact between pedicle screws and bones, between pedicle screws and rods, and within specific parts of each implant component, comprise the regions of greatest potential stress to be considered by the system.”)];
With respect to claim 32, the combination of Parmar, Ballard et al., Hu et al., Hillard, SpineShape and Steinberg et al. discloses the method of claim 31 above, Steinberg et al. further discloses “wherein running the osteotomy simulation includes predicting a stress or strain in the fixation rod or the fixation devices at segments adjacent to the transition region based on the diameter of the transition region, the morphology of the patient, and the predicted loading” as [Steinberg et al. (Pg. 4, 1st paragraph “These stress scores indicate the level of post-operative stress likely to be placed on each individual rod component of the entire implant system at each point along its extent. The regions of contact between pedicle screws and bones, between pedicle screws and rods, and within specific parts of each implant component, comprise the regions of greatest potential stress to be considered by the system.”)];
“and determining the location of the fixation devices includes determining the location of the fixation devices along the transition region, or at an intersection of the transition region and the first section or the second section based on the predicted loading”. as [Steinberg et al. (Pg. 4, 1st paragraph “These stress scores indicate the level of post-operative stress likely to be placed on each individual rod component of the entire implant system at each point along its extent. The regions of contact between pedicle screws and bones, between pedicle screws and rods, and within specific parts of each implant component, comprise the regions of greatest potential stress to be considered by the system.”, Steinberg et al. (Pg. 8 last paragraph “A related method of modeling and predicting long-term success of a bone-implant system adds the following step during the intraoperative implantation procedure: insert into a subject's spine a selected implant, the implant being adapted to have at least one mode of stress detection. Measure the stress at each point along the element with the relevant mode of stress detection, in order to obtain a field pattern of stress of the implant.”, Inserting the implant into a subject’s spine demonstrates that the location of fixation devices is known, since the fixation devices are used to attach the fixation to a patient, see paragraph [0045] of the specification)];
With respect to claim 33, the combination of Parmar, Ballard et al., Hu et al., Hillard, SpineShape and Steinberg et al. discloses the method of claim 32 above, Steinberg et al. further discloses “implanting the fixation rod and the fixation device in the patient” as [Ballard et al. (paragraph [0041] “Once the surgeon 18 is satisfied with the bending of the rod 21, the rod 21 is taken from the back table 20 and positioned in fasteners (e.g., bone screws) 41 previously implanted into the patient 40 on the operating table 30. The surgeon 18 can again adjust the bends in the rod 21. The surgeon 18 then tightens the set screws 42 onto the rod 21 to secure the rod 21 in the fasteners (e.g., bone screws) 41.”)];
“wherein the fixation device is a pedicle assembly attached to the fixation rod and the patient at the determined location”. as [Ballard et al. (paragraph [0041] “Once the surgeon 18 is satisfied with the bending of the rod 21, the rod 21 is taken from the back table 20 and positioned in fasteners (e.g., bone screws) 41 previously implanted into the patient 40 on the operating table 30. The surgeon 18 can again adjust the bends in the rod 21. The surgeon 18 then tightens the set screws 42 onto the rod 21 to secure the rod 21 in the fasteners (e.g., bone screws) 41.”, With attaching the rod to the patient using the fasteners (screws), demonstrates that there’s a pedicle assembly, since a pedicle assembly includes a pedicle screw, see paragraph [0045] of the specification and Fig. 1 of the drawings of the current application)];
With respect to claim 34, the combination of Parmar, Ballard et al., Hu et al., Hillard, SpineShape and Steinberg et al. discloses the method of claim 30 above, Ballard et al. further discloses “wherein the transition region has a frusto-conical shape extended from a first section of the plurality of sections to a second section of the plurality of sections.” as [Ballard et al. (paragraph [0041] “Once the surgeon 18 is satisfied with the bending of the rod 21, the rod 21 is taken from the back table 20 and positioned in fasteners (e.g., bone screws) 41 previously implanted into the patient 40 on the operating table 30. The surgeon 18 can again adjust the bends in the rod 21. The surgeon 18 then tightens the set screws 42 onto the rod 21 to secure the rod 21 in the fasteners (e.g., bone screws) 41.”, Fig. 11, Fig. 11 shows that the screws that are tighten are conical shape)];
“and determining the at least one shape and curvature includes determining a bend in the transition region of at least 1° and at most 90° based on the predicted loading in the fixation rod along the frusto-conical shape” as [Ballard et al. (paragraph [0041] “That is, the surgeon determines a number of bends and angles of the bends to the rod required in the sagittal, coronal and/or transverse planes…….In step s8 the actual value of the measurements can be displayed on display 14 so that the surgeon can confirm that the rod 21 has been bent according to the predetermined geometries. If it is determined in step s9 that the angles/geometries/measurements do not match the predetermined geometries the process can be repeated until the surgeon is satisfied with the results”)];
Hu et al. discloses “determining the morphotype includes determining each of the first diameter and the second diameter to be at least 3mm and at most 6mm, with a maximum difference between the first diameter and the second diameter being 1mm, and a length of the frusto-conical shape to be at least 5mm and at most 40mm based on the predicted loading in the fixation rod along the frusto-conical shape, and based on the predicted variable bending stiffness or the predicted flex of the fixation rod along the frusto-conical shape” as [Hu et al. (Pg. 7, right col. “The wedge shape was set to a 50:50 angle bisector. Upon application of the osteotomy, the image was modified directly: the wedge shape portion was removed, the posterior column closed, and the anterior column opened (Fig. 1d and
Fig. 5d). Then, the key parameters were measured to determine whether sagittal alignment was restored to the normal physiological limits.”, In Fig. 5e and 5g, it can be seen that the screws have a different diameter over the length of the screw)];
Claim(s) 37-38 is/are rejected under 35 U.S.C. 103 as being unpatentable Parmar in
view of Ballard et al. in further view of Hu et al. in further view Steinberg et al. (CA 3116288).
With respect to claim 37, the combination of Parmar, Ballard et al. and Hu et al. discloses the method of claim 1 above, and Ballard et al. further discloses “wherein the morphology includes a spinal column of the patient” as [Ballard et al. (paragraph [0024] “The exemplary embodiments of the system and method for measuring a surgical rod are discussed in terms of medical devices for the treatment of musculoskeletal disorders and more particularly, in terms of a spinal fixation system that provides stabilization for treating a vertebral column…… The present disclosure may also be alternatively employed with procedures for treating the lumbar, cervical, thoracic, sacral and pelvic regions of a spinal column.”)];
While the combination of Parmar, Ballard et al. and Hu et al. teaches running the osteotomy simulation based on pre-surgical measurements of spinal curvature of a patient, Parmar, Ballard et al. and Hu et al. do not explicitly disclose “and running the osteotomy simulation includes: predicting the loading from the fixation rod to the spinal column of the patient, including load transfer to a portion of the spinal column stabilized by the fixation rod, and load transfer to vertebral segments adjacent to the portion of the spinal column; “and generating at least one of a length, diameter, curvature, and slope of the fixation rod at the portion of the spinal column based on the predicted loading.”.
Steinberg et al. discloses “and running the osteotomy simulation includes: predicting the loading from the fixation rod to the spinal column of the patient, including load transfer to a portion of the spinal column stabilized by the fixation rod, and load transfer to vertebral segments adjacent to the portion of the spinal column” as [Steinberg et al. (Pg. 5, last paragraph “A computerized assessment using finite element analysis, which indicates the stress distribution along the implant and the ensuing strains, is then carried out to determine the likely success of each bone-implant system under various levels of mechanical stress.”)];
“and generating at least one of a length, diameter, curvature, and slope of the fixation rod at the portion of the spinal column based on the predicted loading.” as [Steinberg et al. (Pg. 6, 1st paragraph, “Based on the finite element analysis and assessment of implant stability, optimal implant characteristics are selected, including at least some of length and diameter, material and composition, curvature or shape, position and orientation in relationship to the vertebra height, depth and angle.”)];
Parmar, Ballard et al., Hu et al. and Steinberg et al. are analogous art because they are from the same field endeavor of analyzing surgical planning for spinal surgery.
Before the effective filing date of the invention, it would have been obvious to a person
of ordinary skill in the art to modify the teachings of Parmar, Ballard et al. and Hu et al. of running the osteotomy simulation based on pre-surgical measurements of spinal curvature of a patient by incorporating and running the osteotomy simulation includes: predicting the loading from the fixation rod to the spinal column of the patient, including load transfer to a portion of the spinal column stabilized by the fixation rod, and load transfer to vertebral segments adjacent to the portion of the spinal column; “and generating at least one of a length, diameter, curvature, and slope of the fixation rod at the portion of the spinal column based on the predicted loading as taught by Steinberg et al. for the purpose of predicting the level of force on an implant for a patient.
Parmar in view of Ballard et al. in further view of Hu et al. in further view of Steinberg et al. teaches and running the osteotomy simulation includes: predicting the loading from the fixation rod to the spinal column of the patient, including load transfer to a portion of the spinal column stabilized by the fixation rod, and load transfer to vertebral segments adjacent to the portion of the spinal column; “and generating at least one of a length, diameter, curvature, and slope of the fixation rod at the portion of the spinal column based on the predicted loading.
The motivation for doing so would have been because Steinberg et al. teaches that by predicting the level of force on an implant for a patient, the ability to have a favorable long-term surgical outcomes and long-term bone-implant survival can be accomplished. This procedure would make it easier for a surgeon to correct a spine for a patient (Steinberg et al. Pg. 3, Summary, 1st – 2nd paragraph, “There exist a need for a method, etc.”).
With respect to claim 38, the combination of Parmar, Ballard et al., Hu et al. and Steinberg et al. discloses the method of claim 37 above, and Steinberg et al. further discloses “wherein running the osteotomy simulation includes generating a pedicle assembly that attaches the fixation rod to the spinal column” as [Steinberg et al. (Pg. 4, 1st paragraph, “These stress scores indicate the level of post-operative stress likely to be placed on each individual rod component of the entire implant system at each point along its extent. The regions of contact between pedicle screws and bones, between pedicle screws and rods, and within specific parts of each implant component, comprise the regions of greatest potential stress to be considered by the system.”, Steinberg et al. (Pg. 8 last paragraph “A related method of modeling and predicting long-term success of a bone-implant system adds the following step during the intraoperative implantation procedure: insert into a subject's spine a selected implant, the implant being adapted to have at least one mode of stress detection. Measure the stress at each point along the element with the relevant mode of stress detection, in order to obtain a field pattern of stress of the implant.”, With inserting an implant into a subject’s spine with pedicle screws, demonstrates that there’s a pedicle assembly, since a pedicle assembly includes a pedicle screw, see paragraph [0045] of the specification and Fig. 1 of the drawings of the current application)];
“and determining a location of the pedicle assembly along the fixation rod and the spinal column based on the predicted loading in the fixation rod along the morphology at the pedicle assembly, or based on the predicted loading from the fixation rod to the morphology through the pedicle assembly” as [Steinberg et al. (Pg. 4, 1st paragraph, “These stress scores indicate the level of post-operative stress likely to be placed on each individual rod component of the entire implant system at each point along its extent. The regions of contact between pedicle screws and bones, between pedicle screws and rods, and within specific parts of each implant component, comprise the regions of greatest potential stress to be considered by the system.”, Steinberg et al. (Pg. 8 last paragraph “A related method of modeling and predicting long-term success of a bone-implant system adds the following step during the intraoperative implantation procedure: insert into a subject's spine a selected implant, the implant being adapted to have at least one mode of stress detection. Measure the stress at each point along the element with the relevant mode of stress detection, in order to obtain a field pattern of stress of the implant.”)];
“and the method further comprises implanting the fixation rod and the pedicle assembly in the patient, wherein the pedicle assembly is attached to the fixation rod and the patient at the determined locations.” as [Steinberg et al. (Pg. 8 last paragraph “A related method of modeling and predicting long-term success of a bone-implant system adds the following step during the intraoperative implantation procedure: insert into a subject's spine a selected implant, the implant being adapted to have at least one mode of stress detection. Measure the stress at each point along the element with the relevant mode of stress detection, in order to obtain a field pattern of stress of the implant.”)];
Claim(s) 41 is/are rejected under 35 U.S.C. 103 as being unpatentable Parmar
in view of Ballard et al. in further view of o Hu et al. in further view of Steinberg et al. (CA 3116288).
With respect to claim 41, the combination of Parmar, Ballard et al. and Hu et al. discloses the method of claim 40 above, and Hu et al. further discloses “wherein the patient data includes bone quality at the morphology” as [Hu et al. (Pg. 4, Operative technique, 2nd paragraph, “Then, VCD was performed (Fig. 3). A pedicle probe and drill were used to create and enlarge relatively normal pedicle holes in the target vertebra on both sides of the pedicles. Cancellous bone of the posterior half of the osteotomy column was adequately removed through the pedicle holes, using a rongeur and curette. A high-speed drill was used to thin the anterior cortex and lateral walls of the vertebral body and linear fractures of the anterior cortex were created using an osteotome. Then the spinal canal was opened laterally, and the posterior elements including the spinous process, bilateral lamina, transverse process, and the adjacent facet joints were removed. After removing the posterior cortical bone of the osteotomized vertebra, the kyphotic spine was corrected using gentle manual force, and was stabilized with a
temporary rod.”)];
While the combination of Parmar, Ballard et al. and Hu et al. teaches running the osteotomy simulation includes generating fixation devices that attach the fixation rod to the morphology of the patient, Parmar, Ballard et al. and Hu et al. do not explicitly disclose “and performing the osteotomy simulation includes determining the loading from the fixation rod to the morphology, and includes matching the bone quality to the one or more of the fixation rod morphotypes”
Steinberg et al. discloses “and performing the osteotomy simulation includes determining the loading from the fixation rod to the morphology, and includes matching the bone quality to the one or more of the fixation rod morphotypes” as [Steinberg et al. (Pg. 4, 1st paragraph “These stress scores indicate the level of post-operative stress likely to be placed on each individual rod component of the entire implant system at each point along its extent. The regions of contact between pedicle screws and bones, between pedicle screws and rods, and within specific parts of each implant component, comprise the regions of greatest potential stress to be considered by the system.”, Steinberg et al. Pg. 5, last paragraph “A computerized assessment using finite element analysis, which indicates the stress distribution along the implant and the ensuing strains, is then carried out to determine the likely success of each bone-implant system under various levels of mechanical stress.”)];
Parmar, Ballard et al., Hu et al. and Steinberg et al. are analogous art because they are from the same field endeavor of analyzing surgical planning for spinal surgery.
Before the effective filing date of the invention, it would have been obvious to a person
of ordinary skill in the art to modify the teachings of Parmar, Ballard et al. and Hu et al. of running the osteotomy simulation includes generating fixation devices that attach the fixation rod to the morphology of the patient by incorporating and performing the osteotomy simulation includes determining the loading from the fixation rod to the morphology, and includes matching the bone quality to the one or more of the fixation rod morphotypes as taught by Steinberg et al. for the purpose of predicting the level of force on an implant for a patient.
Parmar in view of Ballard et al. in further view of Hu et al. in further view of Steinberg et al. teaches and performing the osteotomy simulation includes determining the loading from the fixation rod to the morphology, and includes matching the bone quality to the one or more of the fixation rod morphotypes.
The motivation for doing so would have been because Steinberg et al. teaches that by predicting the level of force on an implant for a patient, the ability to have a favorable long-term surgical outcomes and long-term bone-implant survival can be accomplished. This procedure would make it easier for a surgeon to correct a spine for a patient (Steinberg et al. Pg. 3, Summary, 1st – 2nd paragraph, “There exist a need for a method, etc.”).
Claim(s) 42 is/are rejected under 35 U.S.C. 103 as being unpatentable Parmar
in view of Ballard et al. in further view of o Hu et al. in further view of Steinberg et al. (CA 3116288).
With respect to claim 42, the combination of Parmar, Ballard et al. and Hu et al. discloses the method of claim 1 above, and Ballard et al. further discloses “inputting fixation rod morphologies and corresponding post operative data into the computer system” as [Ballard et al. (paragraph [0041] “As a general rule, after making the decision to implant a fixation system into a patient, a surgeon will take a plurality of spinal measurements of the patient and determine the precise geometries required for the spinal rod. That is, the surgeon determines a number of bends and angles of the bends to the rod required in the sagittal, coronal and/or transverse planes. These predetermined/preoperative measurements are brought into the operating room where the rod 21 is initially bent on a back table 20 prior to being positioned within the patient 40. The preoperative measurements can also be input into the measuring system 10 and stored in memory 13 for later use in confirming the proper bending of the rod 21”)];
While the combination of Parmar, Ballard et al. and Hu et al. teaches running the osteotomy simulation includes generating fixation devices that attach the fixation rod to the morphology of the patient, Parmar, Ballard et al. and Hu et al. do not explicitly disclose “wherein performing the osteotomy simulation includes: generating the at least one shape and curvature by determining a length of a transition region of the fixation rod based on the predicted loading in the fixation rod or the predicted loading from the fixation rod to the morphology of the patient; wherein the transition region is positioned at the junction and has a diameter that gradually tapers between adjacent sections of the fixation rod, and the adjacent sections have different diameters”
Steinberg et al. discloses “wherein performing the osteotomy simulation includes: generating the at least one shape and curvature by determining a length of a transition region of the fixation rod based on the predicted loading in the fixation rod or the predicted loading from the fixation rod to the morphology of the patient” as [Steinberg et al. (Pg. 5, last paragraph “A computerized assessment using finite element analysis, which indicates the stress distribution along the implant and the ensuing strains, is then carried out to determine the likely success of each bone-implant system under various levels of mechanical stress.”, Steinberg et al. (Pg. 6, 1st paragraph, “Based on the finite element analysis and assessment of implant stability, optimal implant characteristics are selected, including at least some of length and diameter, material and composition, curvature or shape, position and orientation in relationship to the vertebra height, depth and angle.”)];
“wherein the transition region is positioned at the junction and has a diameter that gradually tapers between adjacent sections of the fixation rod, and the adjacent sections have different diameters” as [Steinberg et al. (Pg. 6, 1st paragraph, “Based on the finite element analysis and assessment of implant stability, optimal implant characteristics are selected, including at least some of length and diameter, material and composition, curvature or shape, position and orientation in relationship to the vertebra height, depth and angle.”)];
Parmar, Ballard et al., Hu et al. and Steinberg et al. are analogous art because they are from the same field endeavor of analyzing surgical planning for spinal surgery.
Before the effective filing date of the invention, it would have been obvious to a person
of ordinary skill in the art to modify the teachings of Parmar, Ballard et al. and Hu et al. of running the osteotomy simulation includes generating fixation devices that attach the fixation rod to the morphology of the patient by incorporating wherein performing the osteotomy simulation includes: generating the at least one shape and curvature by determining a length of a transition region of the fixation rod based on the predicted loading in the fixation rod or the predicted loading from the fixation rod to the morphology of the patient; wherein the transition region is positioned at the junction and has a diameter that gradually tapers between adjacent sections of the fixation rod, and the adjacent sections have different diameters as taught by Steinberg et al. for the purpose of predicting the level of force on an implant for a patient.
Parmar in view of Ballard et al. in further view of Hu et al. in further view of Steinberg et al. teaches wherein performing the osteotomy simulation includes: generating the at least one shape and curvature by determining a length of a transition region of the fixation rod based on the predicted loading in the fixation rod or the predicted loading from the fixation rod to the morphology of the patient; wherein the transition region is positioned at the junction and has a diameter that gradually tapers between adjacent sections of the fixation rod, and the adjacent sections have different diameters.
The motivation for doing so would have been because Steinberg et al. teaches that by predicting the level of force on an implant for a patient, the ability to have a favorable long-term surgical outcomes and long-term bone-implant survival can be accomplished. This procedure would make it easier for a surgeon to correct a spine for a patient (Steinberg et al. Pg. 3, Summary, 1st – 2nd paragraph, “There exist a need for a method, etc.”).
Conclusion
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/BERNARD E COTHRAN/Examiner, Art Unit 2188
/RYAN F PITARO/Supervisory Patent Examiner, Art Unit 2188