DETAILED ACTION
1. This office action is in responsive to the applicant’s arguments filed on 3/31/26.
2. The present application is being examined under the first inventor to file provisions of the AIA .
3. Claims 1-7 and 30-45 are currently pending.
4. Claims 1-4, 6-7, 34, 37-38 and 40-42 are amended.
5. Claims 5, 30-33, 35-36, 39 are previously presented.
6. Claims 8-29 are canceled. Claims 43-45 are new.
Response to Arguments
Response: 35 U.S.C. § 103
7. Examiner Response:
Applicant’s arguments, see pages 21-26, filed 3/31/26, with respect to the 35 U.S.C. 103 rejections have been fully considered and are persuasive. The 35 U.S.C. 103 rejections of claims 1-7 and 30-42 has been withdrawn.
Response: 35 U.S.C. § 101
8. Applicants argue:
The applicant argues that the current claims are not directed towards an abstract idea but
rather to a structured computational sequence that produces a tangible, patient-specific fixation
rod configuration. The applicant points to the McRo, Inc. v. Bandai Namco Games Am. Inc.,
court case for support as to why the current claims are eligible under 35 U.S.C. 101. (Remarks:
page 11)
9. Examiner Response:
The applicant points to the McRO court case for support as to why the claim language is
not directed towards an abstract idea. The examiner notes that in the McRO case, the court used
a claim construction analysis, interpreting the claimed “first set of rules” as being limited to rules
that evaluate sub-sequences consisting of multiple sequential phonemes. Under this
interpretation, the court found while the claims may not recite a particular species of rules to be
applied, they are still limited to a particular genus of rules (i.e., those that evaluate sequences of
multiple phonemes) and therefore do not preempt all rules-based techniques for solving the
problem at hand. The applicant argues that the current claim language is directed towards a
structured computational sequence that produces a tangible, patient-specific fixation
rod configuration. The examiner notes that the current claims do not teach an unconventional
way (sequence) of generating and bending a surgical rod. This can be seen in the last limitation
of claim 1 that states “intraoperatively bending the one of the fixation rods to the at least one
shape and curvature”, where a surgeon can do the bending of the rod. Therefore, the amended
claims are still not eligible under 35 U.S.C. 101.
10. Applicants argue:
The applicant argues that the amended claims teach physical manufacturing steps that are
integrated into the computational workflow. The applicant points to the In re Brown case for
support as to why the amended claims are eligible under 35 U.S.C. 101. The applicant also
argues that the cutting the hair step (step e)) is a meaningful and necessary limitation, and
that the scissors used in that step render the claims patent eligible under 35 U.S.C. 101.
(Remarks: pages 11-12)
11. Examiner Response:
The examiner notes that the current claim language is a manual process of bending a rod
using the abstract idea. The recent amended limitations such as “preoperatively machining a plurality of fixation rods to fixation rod morphotypes with diameters or lengths different from each other” amounts to mere instructions to apply an exception, where it recites an idea of a solution. The limitation doesn’t indicate how the plurality of fixation rods 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".
Also, the recently amended limitation that states “matching a fixation rod morphotype of one of the fixation rods to the at least one shape and curvature, based on the predicted amount of stress or strain” amounts to mere instructions to apply an exception, where it recites an idea of a solution. The limitation doesn’t indicate what is doing the matching of a fixation rod morphotype of one of the fixation rods is being conducted of how the matching 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 amended limitation that states “and intraoperatively bending the one of the fixation rods 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".
12. Applicants argue:
The applicant argues that the generating, predicting and matching limitations cannot be
conducted in the human mind or with pencil and paper. The applicant points to the American Axle & Manufacturing, Inc. v. Neapco Holdings LLC, court case for support as to why the current claims are eligible under 35 U.S.C. 101. (Remarks: pages 12-13)
13. Examiner Response:
The examiner respectfully disagrees. The examiner notes that the limitation of
claim 1 that states “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 examiner notes that the limitation of claim 1 that states “generating at least one shape and curvature including a bend 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 examiner notes that the limitation of claim 1 that states “predicting loading including at least one of a loading in the fixation rod, a loading in the morphology, 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 examiner notes that the limitation of claim 1 that states “predicting an amount of stress or strain of the fixation rod or the morphology based on the predicted loading” mounts to mere instructions to apply an exception, where it recites an idea of a solution. The limitation doesn’t indicate how the predicting is occurring. 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 examiner notes that the limitation of claim 1 that states “matching a fixation rod morphotype of one of the fixation rods to the at least one shape and curvature, based on the predicted amount of stress or strain” amounts to mere instructions to apply an exception, where it recites an idea of a solution. The limitation doesn’t indicate what is doing the matching of a fixation rod morphotype of one of the fixation rods is being conducted of how the matching 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".
The examiner notes that the applicant points to the American Axle & Manufacturing, Inc.
court case for support as to why the current claims are eligible under 35 U.S.C. 101. The examiner notes that for the American Axle & Manufacturing, Inc. case the Federal Circuit found that the tuning within the claim language amounted to an instruction to apply Hooke’s Law, where one of ordinary skill in the art could achieve the claimed result. The examiner notes that the current limitation of claim 1 do not involve using math, where it would fall within the “Mathematical Concept” grouping of abstract ideas. However, the recently amended claims do not teach an unconventional way (sequence) of generating and bending a surgical rod. This can be seen in the last limitation of claim 1 that states “intraoperatively bending the one of the fixation rods to the at least one shape and curvature”, where a surgeon can do the bending of the rod.
Also, as shown above, the generating, predicting and matching limitations of claim 1 fall under step 2A Prong 1 or step 2A Prong 2, where the claim is not eligible under 35 U.S.C.101.
14. Applicants argue:
The applicant argues that the current claims integrate the alleged abstract idea into a practical application, where the claims recite a concrete improvement to spinal fixation rod manufacturing. The applicant points to the matching, predicting and intraoperatively bending limitations of claim 1 as being limitations that integrate the alleged abstract idea into a practical application. (Remarks: pages 13-15)
15. Examiner Response:
The examiner respectfully disagrees. The examiner notes that the predicting limitation of claim 1 that state “predicting loading including at least one of a loading in the fixation rod, a loading in the morphology, 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 predicting limitation of claim 1 that states “predicting an amount of stress or strain of the fixation rod or the morphology based on the predicted loading” mounts to mere instructions to apply an exception, where it recites an idea of a solution. The limitation doesn’t indicate how the predicting is occurring. 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 matching limitation of claim 1 that states “matching a fixation rod morphotype of one of the fixation rods to the at least one shape and curvature, based on the predicted amount of stress or strain” amounts to mere instructions to apply an exception, where it recites an idea of a solution. The limitation doesn’t indicate what is doing the matching of a fixation rod morphotype of one of the fixation rods is being conducted of how the matching 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 “and intraoperatively bending the one of the fixation rods 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 recites the additional elements of a computer. The computer is 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.
Further, the examiner notes that as stated above in sections 9 and 13 of the current office
action, the current claims do not teach an unconventional way (sequence) of generating and
bending a surgical rod. This can be seen in the last limitation of claim 1 that states
“intraoperatively bending the one of the fixation rods to the at least one shape and curvature”,
where a surgeon can do the bending of the rod. Therefore, the amended claims are still not
eligible under 35 U.S.C. 101.
16. Applicants argue:
The applicant argues that the current claims integrate the alleged abstract idea into practical application because the simulation outputs culminate in a particular treatment of the patient. The applicant points to MPEP 2106.05(e) and the Classen Immunotherapies, Inc. v. Biogen IDEC court case for support.
Also, the applicant points to dependent claims 5, 33, 35 and 38 as reinforcing the treatment-specific integration. (Remarks: pages 15-16)
17. Examiner Response:
The examiner respectfully disagrees. The examiner notes that in the Classen
Immunotherapies Inc. court case the Classen patents are directed towards a method of lowering
the risk of chronic immune-mediated disorder. The claims that were considered eligible under 35
U.S.C. 101 discovery that a particular schedule of infant immunization for infectious diseases
can affect the later occurrence of chronic immune-mediated disorders. The claims of the current
application do not teach an unconventional way (sequence) of generating and
bending a surgical rod. This can be seen in the last limitation of claim 1 that states
“intraoperatively bending the one of the fixation rods to the at least one shape and curvature”,
where a surgeon can do the bending of the rod. Therefore, the amended claims are still not
eligible under 35 U.S.C. 101.
Also, the examiner notes that 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".
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”.
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".
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 location.”. 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.
18. Applicants argue:
The applicant argues that the claims include additional elements that amount to significantly more than the alleged abstract idea under Step 2B. The applicant also argues that the ordered combination of the additional elements in claim 1 are non-conventional and non-generic in the spinal fixation art and points to the BASCOM Global Internet Services, Inc. v. AT&T Mobility LLC court case for support.
The applicant also points to dependent claims 31-32, 39-40 and claim 5 to further the specificity to the ordered combination. (Remarks: pages 16-18)
19. Examiner Response:
The examiner respectfully disagrees. The examiner notes that claim 1 recites the additional elements of a computer. The computer is 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.
The applicant also looks to the Bascom case for support as to why the claims are patentable under 35 U.S.C. 101. The examiner notes that in the Bascom case, the courts determined that the claims were directed to patentable subject matter based on the particular arrangement of generic and conventional components in the claims. The claims of the Bascom case filter content into a particular, practical application of that abstract idea. The examiner notes that the amended claim language of claim 1 does not integrate the abstract idea into a practical application.
The limitation of “preoperatively machining a plurality of fixation rods to fixation rod morphotypes with diameters or lengths different from each other” amounts to mere instructions to apply an exception, where it recites an idea of a solution. The limitation doesn’t indicate how the plurality of fixation rods 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".
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 claim 1 recites “generating at least one shape and curvature including a bend 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.
Also, the limitation of “predicting loading including at least one of a loading in the fixation rod, a loading in the morphology, 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 “predicting an amount of stress or strain of the fixation rod or the morphology based on the predicted loading” mounts to mere instructions to apply an exception, where it recites an idea of a solution. The limitation doesn’t indicate how the predicting is occurring. 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 “matching a fixation rod morphotype of one of the fixation rods to the at least one shape and curvature, based on the predicted amount of stress or strain” amounts to mere instructions to apply an exception, where it recites an idea of a solution. The limitation doesn’t indicate what is doing the matching of a fixation rod morphotype of one of the fixation rods is being conducted of how the matching 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 “and intraoperatively bending the one of the fixation rods 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".
The examiner also notes that dependent claims 31-32, 39-40 and claim 5 are also rejected under 35 U.S.C. 101.
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 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 of post-operative fixation rod morphologies, 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 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".
As stated above, the current limitations shown above, does not integrate the abstract idea into a practical application.
20. Applicants argue:
The applicant argues that the previous office action does not satisfy the evidentiary
requirements for a Step 2B. The applicant points to the recently added and amended limitations
of claim 1 that states preoperatively machining spinal fixation rods to a morphotype inventory,
running a biomechanical simulation that predicts loading and stress or strain to match a
morphotype, or intraoperatively bending a matched morphotype rod to a simulation-determined
shape in the spinal fixation art, do not support the conventionality of generic computer hardware
and data storage. (Remarks: pages 18-19)
21. Examiner Response:
The examiner first notes that the preoperatively machining, the predicting an amount of
stress, the matching and the intraoperatively bending limitations were not in the previously
submitted claims or were not written as written in the currently filed claims. Therefore, the those
limitations were not rejected in the previous office action.
Also, under Step 2B, the preoperatively machining limitation that states “preoperatively machining a plurality of fixation rods to fixation rod morphotypes with diameters or lengths different from each other” amounts to mere instructions to apply an exception, where it recites an idea of a solution. The limitation doesn’t indicate how the plurality of fixation rods 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".
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 an amount of stress or strain of the fixation rod or the morphology based on the predicted loading” mounts to mere instructions to apply an exception, where it recites an idea of a solution. The limitation doesn’t indicate how the predicting is occurring. 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 “matching a fixation rod morphotype of one of the fixation rods to the at least one shape and curvature, based on the predicted amount of stress or strain” amounts to mere instructions to apply an exception, where it recites an idea of a solution. The limitation doesn’t indicate what is doing the matching of a fixation rod morphotype of one of the fixation rods is being conducted of how the matching 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 “and intraoperatively bending the one of the fixation rods 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".
22. Applicants argue:
The applicant argues that claim 39, 40 and 44 are distinguishable from generic machine
learning recitation that weas found ineligible in the Vehicle Intelligence Safety LLC v.
Mercedes-Benz court case.
The applicant also argues that claim 39, 40 and 44 teaches machine learning that is not
incidental to the claimed workflow. The applicant argues that each claim directly constrain the
physical manufacturing and surgical implementation steps of claim 1. (Remarks: pages 19-20)
23. Examiner Response:
The examiner notes that 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.
Dependent claim 40 recites “wherein matching the morphotype of the patient to the fixation rod morphologies includes storing the morphologies as a condensed distillation of post-operative fixation rod morphologies, 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.
Dependent claim 44 recites “wherein matching the fixation rod morphotype includes using a model operating on a database of pre-operative rod data and post-operative rod data to predict construct unloading in situ from rod flex based on lengths and diameters of constant diameter segments and transition regions of the fixation rod”. 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 rod flex is associated with the pre-operative rod data and post-operative rod data. 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 44 recites “predicting adjacent segment strain, stress, or failure from those features, and selecting the fixation rod morphotype based on the prediction.”. This limitation amounts to mere instructions to apply an exception, where it recites an idea of a solution. The limitation doesn’t indicate what the features are. 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 examiner notes that unconventional machine learning is not within the
current claim language. It can be seen within the dependent claims shown above that the
applicant points to and the limitations of claim 1 shown above in sections 11 and 13 of the
current office action.
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 30-45 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 including a bend 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 “preoperatively machining a plurality of fixation rods to fixation rod morphotypes with diameters or lengths different from each other” amounts to mere instructions to apply an exception, where it recites an idea of a solution. The limitation doesn’t indicate how the plurality of fixation rods 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".
Also, the limitation of “inputting data from pre-surgical measurements of spinal curvature of a patient into a computer system” 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, a loading in the morphology, 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 “predicting an amount of stress or strain of the fixation rod or the morphology based on the predicted loading” mounts to mere instructions to apply an exception, where it recites an idea of a solution. The limitation doesn’t indicate how the predicting is occurring. 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 “matching a fixation rod morphotype of one of the fixation rods to the at least one shape and curvature, based on the predicted amount of stress or strain” amounts to mere instructions to apply an exception, where it recites an idea of a solution. The limitation doesn’t indicate what is doing the matching of a fixation rod morphotype of one of the fixation rods is being conducted of how the matching 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 “and intraoperatively bending the one of the fixation rods 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 element of the 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 computer. The computer is 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 “preoperatively machining a plurality of fixation rods to fixation rod morphotypes with diameters or lengths different from each other” amounts to mere instructions to apply an exception, where it recites an idea of a solution. The limitation doesn’t indicate how the plurality of fixation rods 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".
Also, the limitation of “inputting data from pre-surgical measurements of spinal curvature of a patient into a computer system” 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, a loading in the morphology, and a loading from the fixation rod to the morphology” s 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 “predicting an amount of stress or strain of the fixation rod or the morphology based on the predicted loading” mounts to mere instructions to apply an exception, where it recites an idea of a solution. The limitation doesn’t indicate how the predicting is occurring. 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 “matching a fixation rod morphotype of one of the fixation rods to the at least one shape and curvature, based on the predicted amount of stress or strain” amounts to mere instructions to apply an exception, where it recites an idea of a solution. The limitation doesn’t indicate what is doing the matching of a fixation rod morphotype of one of the fixation rods is being conducted of how the matching 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 “and intraoperatively bending the one of the fixation rods 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 computer 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 in the patient with the fixation rod morphotype and the at least one shape and curvature determined in the osteotomy simulation”. 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 at least one shape and curvature is associated with 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 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.”. 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 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 “matching the fixation rod morphotype 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 or a flex of the fixation rod is associated with a local diameter of each of the sections. 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 using 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 first section and second section that 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 comprises a transition region positioned between the first section and the second section along 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.
Dependent claim 6 recites “the transition region having a variable diameter that gradually transitions between the different diameters of the first section and the second section”. 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 running the osteotomy simulation includes: calculating a Bezier curve that defines a longitudinal axis of the fixation rod based on the predicted stress or strain by determining a set of discrete control points that define a smooth, continuous curve through the transition region”. This limitation is calculating a Bezier curve that defines a longitudinal axis of the fixation rod. 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 7 recites “and generating the at least one shape and curvature includes generating the transition region with the bend following the Bezier curve”. 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 transition region is associated with Bezier curve. 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 7 recites “and positioned above or below a thoracolumbar junction or a cervical thoracic junction along the spinal curvature of the patient”. his 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 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 the first section to the second section, such that the first section, the second section, and the transition region are monolithically formed with each other.”. 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 “inputting pre-operative rod data and post-operative rod data from prior patients 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 37 recites “wherein the pre- operative rod data and the post-operative rod data indicate failures of vertebral segments adjacent to fixation rods implanted in the prior patients”. 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 37 recites “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 “predicting a likelihood of adjacent segment failure based on the load transfer to the vertebral segments adjacent to the portion of the spinal column using failure predictors from the pre-operative rod data and the post-operative rod 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 failure predictors from the pre-operative rod data and the post-operative rod data are associated with the load transfer to the vertebral segments. 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 location.”. 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 of post-operative fixation rod morphologies, 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 inputted data includes bone quality at a plurality of regions along 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 “predicting the loading includes determining the loading from the fixation rod to the morphology or determining the loading in the morphology at each of the plurality of regions”. 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 41 recites “and includes matching the bone quality to the one or more of the fixation rod morphotypes”. 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 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 a junction along a spinal column of the patient 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.
Claim 43
Dependent claim 43 recites “wherein the inputted data includes at least one of pelvic incidence, sagittal balance, sacral parameters, or Cobb angles”. 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 43 recites “and running the osteotomy simulation includes calculating lengths and diameters of constant diameter segments and lengths of Bezier curve transition regions that taper between adjacent constant diameter segments of different diameters from the inputted data.”. This limitation is calculating the lengths and diameters of constant diameter segments and lengths of Bezier curve transition regions. Therefore, under MPEP 2106.04(a)(2), this limitation covers a mathematical concept, which falls in the “Mathematical Concept” grouping of abstract ideas.
Claim 44
Dependent claim 44 recites “wherein matching the fixation rod morphotype includes using a model operating on a database of pre-operative rod data and post-operative rod data to predict construct unloading in situ from rod flex based on lengths and diameters of constant diameter segments and transition regions of the fixation rod”. 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 rod flex is associated with the pre-operative rod data and post-operative rod data. 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 44 recites “predicting adjacent segment strain, stress, or failure from those features, and selecting the fixation rod morphotype based on the prediction.”. This limitation amounts to mere instructions to apply an exception, where it recites an idea of a solution. The limitation doesn’t indicate what the features are. 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 45
Dependent claim 45 recites “wherein running the osteotomy simulation includes generating the fixation rod along a Bezier curve, and predicting a flex of the fixation rod with different lengths of a constant diameter segment and a transition region following the Bezier curve”. 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 rod is generated along the Bezier curve. 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 45 recites “wherein lengthening the constant diameter segment is offset by shortening the transition region.”. 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.
Claims 1-7 and 30-45 are therefore not drawn to eligible subject matter as they are directed to an abstract idea without significantly more.
Allowable Subject Matter
The following is an examiner’s statement of reasons for allowance: While nline reference
With AI, 3D imaging and a robot, Medtronic Spine aims to leave competitors bent out of shape, written by Parmar teaches using an AI-driven plan and predictive modeling tools for spinal surgery and generating a custom multi-diameter fixation rod, Ballard et al. (U.S. PGPub 2014/0316420) teaches determining geometries of a surgical rod to provide stabilization of a vertebrae, 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. teaches evaluating the efficacy of Vertebral column decancellation planned preoperatively, Hillard (U.S. Patent 443,764) teaches improving appliances for applying extension to the spinal column of children and persons or animals, online reference SpineShape The dynamic solution for your back Technical information to System IV, written by SpineShape teaches stabilizing the lumbar vertebrae and intervertebral discs through flexible rods, Steinberg et al. (CA 3116288) teaches predicting the level of force on an implant for a patient, none of these reference taken either alone or in combination with the prior art of record disclose, running an osteotomy simulation with the computer system based on the inputted data, including: predicting loading including at least one of a loading in the fixation rod, a loading in the morphology, and a loading from the fixation rod to the morphology; matching a fixation rod morphotype from of one of the fixation rods to the at least one shape and curvature based on the predicted amount of stress or strain; intraoperatively bending the one of the fixation rods to the at least one shape and curvature:
Claim 1 “running an osteotomy simulation with the computer system based on the inputted data, including: predicting loading including at least one of a loading in the fixation rod, a loading in the morphology, and a loading from the fixation rod to the morphology”
“matching a fixation rod morphotype from of one of the fixation rods to the at least one shape and curvature based on the predicted amount of stress or strain”
“intraoperatively bending the one of the fixation rods to the at least one shape and curvature”, in combination with the remaining elements and features of the claimed invention.
It is for these reasons that the applicant’s invention defines over the prior art of record.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/BERNARD E COTHRAN/Examiner, Art Unit 2188
/RYAN F PITARO/Supervisory Patent Examiner, Art Unit 2188
