DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 12-18 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Casey et al. (US 2021/0059822 A1).
Claim 12. Casey discloses a method for selecting a spinal fusion implant for insertion between the endplates of adjacent vertebrae comprising the steps of:
Obtaining a radiodensity scan of the endplate of either vertebra of the vertebrae to contact the implant (see paras. 0026-0027 and 0038, which refer to CT scanning and radiodensity);
Selecting a proposed implant (see Fig. 16, which shows kit 240 including multiple implants 242) having a superior central opening and an inferior central opening (see axial view 214 of Fig. 15, which shows that central openings are occupied by lattice 231; see also Fig. 1, which shows a variety of implants having central openings, and Fig. 4, which shows implant 60 with apertures 82 that allow bone to grow from the endplates through the implant for fusion as stated in para. 0045);
Placing an image of the contact surface area of the implant on the radiodensity scan of the endplate (see para. 0076, which refers to radiodensity images; see paras. 0095, which refers to the use of virtual models, procedures, surgical plans, implants, graphics and/or images; see para. 0098, which refers to manipulating an image and adding a virtual implant to the image);
Determining a Hounsfield Unit score of the endplate (see para. 0076, which refers to voxels rendered in Hounsfield units for bone density) that correlates to a Hounsfield Parameter value based on the given area of the vertebra location that determined the Hounsfield Unit score (see para. 0076, which refers to voxels rendered in Hounsfield units for bone density and the differences in the voxels between cortical and cancellous tissue; see para. 0079, which refers to using the Hounsfield units to select the implant and selecting the implant to avoid subsidence; note that because Casey’s goal is to avoid subsidence, it is apparent that there is a calculation of the Hounsfield Parameter value, which the Examiner is interpreting to be calculated by the computer);
Selecting to use the implant if the Hounsfield Parameter value is between about −5.0 and 8.0 (see para. 0079, which refers to using the Hounsfield units to select the implant and selecting the implant to avoid subsidence; note that because Casey’s goal is to avoid subsidence, it is apparent that the Hounsfield Parameter value, which the Examiner is interpreting to be calculated by the computer, would be between -5.0 and 8.0 as para. 0068 of Applicant’s disclosure states that -5.0 to 0.5 has a low risk of subsidence and 0.5 to 8.0 has a medium risk of subsidence – because Casey’s goal is to avoid subsidence, it is apparent that the range would not include 8.0 to 250 as such is identified by Applicant in para. 0068 as a high-risk region).
Claim 13. Casey discloses confirming that the superior and inferior central openings are adequate to permit fusion (see para. 0045, which refers to apertures 82 configured to allow bone to grow from the endplates through the implant for fusion).
Claim 14. Casey discloses method for selecting a spinal fusion implant for insertion between the endplates of adjacent vertebrae comprising the steps of:
Obtaining a radiodensity scan of the endplate of either vertebra of the vertebrae to contact the implant (see paras. 0026-0027 and 0038, which refer to CT scanning and radiodensity);
Selecting a first implant (see Fig. 16, which shows kit 240 including multiple implants 242) having first medial and lateral dimensions and a superior central opening and an inferior central opening defining a first contact surface area (see axial view 214 of Fig. 15, which shows that central openings are occupied by lattice 231; see also Fig. 1, which shows a variety of implants having central openings, and Fig. 4, which shows implant 60 with apertures 82 that allow bone to grow from the endplates through the implant for fusion as stated in para. 0045);
Placing an image of the first contact surface area on the radiodensity scan of the endplate (see para. 0076, which refers to radiodensity images; see paras. 0095, which refers to the use of virtual models, procedures, surgical plans, implants, graphics and/or images; see para. 0098, which refers to manipulating an image and adding a virtual implant to the image); and
Determining a Hounsfield Unit score of the endplate (see para. 0076, which refers to voxels rendered in Hounsfield units for bone density) that correlates to a Hounsfield Parameter value based on the given area of the vertebra location that determined the Hounsfield Unit score (see para. 0076, which refers to voxels rendered in Hounsfield units for bone density and the differences in the voxels between cortical and cancellous tissue; see para. 0079, which refers to using the Hounsfield units to select the implant and selecting the implant to avoid subsidence; note that because Casey’s goal is to avoid subsidence, it is apparent that there is a calculation of the Hounsfield Parameter value, which the Examiner is interpreting to be calculated by the computer).
Claim 15. Casey discloses the steps of:
Selecting a second implant (see Fig. 16, which shows kit 240 including multiple implants 242) having second medial and lateral dimensions different from the first medial and lateral dimensions of the first selected implant (see para. 0070, which states that the implants have different dimensions) and a second superior central opening and a second inferior central opening defining a second contact surface area (see axial view 214 of Fig. 15, which shows that central openings are occupied by lattice 231; see also Fig. 1, which shows a variety of implants having central openings, and Fig. 4, which shows implant 60 with apertures 82 that allow bone to grow from the endplates through the implant for fusion as stated in para. 0045);
Placing an image of the second contact surface area on the radiodensity scan of the endplate (see para. 0076, which refers to radiodensity images; see paras. 0095, which refers to the use of virtual models, procedures, surgical plans, implants, graphics and/or images; see para. 0098, which refers to manipulating an image and adding a virtual implant to the image); and
Determining a Hounsfield Unit score of the endplate (see para. 0076, which refers to voxels rendered in Hounsfield units for bone density) that correlates to a Hounsfield Parameter value based on the given area of the vertebra location that determined the Hounsfield Unit score (see para. 0076, which refers to voxels rendered in Hounsfield units for bone density and the differences in the voxels between cortical and cancellous tissue; see para. 0079, which refers to using the Hounsfield units to select the implant and selecting the implant to avoid subsidence; note that because Casey’s goal is to avoid subsidence, it is apparent that there is a calculation of the Hounsfield Parameter value, which the Examiner is interpreting to be calculated by the computer).
Claim 16. Casey discloses the steps of:
Selecting either the first or second implant based on the Hounsfield Parameter value of between −5.0 and 8.0 (see para. 0079, which refers to using the Hounsfield units to select the implant and selecting the implant to avoid subsidence; note that because Casey’s goal is to avoid subsidence, it is apparent that the Hounsfield Parameter value, which the Examiner is interpreting to be calculated by the computer, would be between -5.0 and 8.0 as para. 0068 of Applicant’s disclosure states that -5.0 to 0.5 has a low risk of subsidence and 0.5 to 8.0 has a medium risk of subsidence – because Casey’s goal is to avoid subsidence, it is apparent that the range would not include 8.0 to 250 as such is identified by Applicant in para. 0068 as a high-risk region).
Claim 17. Casey discloses wherein the second implant is selected so that the second contact area of the second implant is substantially the same as the first contact area of the first implant (see para. 0070, which states that the implants have different dimensions corresponding to the vertebral level).
Claim 18. Casey discloses method for selecting a spinal fusion implant for insertion between the endplates of adjacent vertebrae comprising the steps of:
Obtaining a radiodensity scan of the endplate of either vertebra of the vertebrae to contact the implant (see paras. 0026-0027 and 0038, which refer to CT scanning and radiodensity);
Selecting a first implant (see Fig. 16, which shows kit 240 including multiple implants 242) having first medial and lateral dimensions and a superior central opening and an inferior central opening defining a first contact surface area (see axial view 214 of Fig. 15, which shows that central openings are occupied by lattice 231; see also Fig. 1, which shows a variety of implants having central openings, and Fig. 4, which shows implant 60 with apertures 82 that allow bone to grow from the endplates through the implant for fusion as stated in para. 0045);
Placing an image of the first contact surface area on the radiodensity scan of the endplate (see para. 0076, which refers to radiodensity images; see paras. 0095, which refers to the use of virtual models, procedures, surgical plans, implants, graphics and/or images; see para. 0098, which refers to manipulating an image and adding a virtual implant to the image);
Determining a Hounsfield Unit score of the endplate (see para. 0076, which refers to voxels rendered in Hounsfield units for bone density) that correlates to a Hounsfield Parameter value based on the given area of the vertebra location that determined the Hounsfield Unit score for the first implant (see para. 0076, which refers to voxels rendered in Hounsfield units for bone density and the differences in the voxels between cortical and cancellous tissue; see para. 0079, which refers to using the Hounsfield units to select the implant and selecting the implant to avoid subsidence; note that because Casey’s goal is to avoid subsidence, it is apparent that there is a calculation of the Hounsfield Parameter value, which the Examiner is interpreting to be calculated by the computer);
Selecting a second implant (see Fig. 16, which shows kit 240 including multiple implants 242) having second medial and lateral dimensions different from the first medial and lateral dimensions of the first selected implant (see para. 0070, which states that the implants have different dimensions) and a second superior central opening and a second inferior central opening defining a second contact surface area (see axial view 214 of Fig. 15, which shows that central openings are occupied by lattice 231; see also Fig. 1, which shows a variety of implants having central openings, and Fig. 4, which shows implant 60 with apertures 82 that allow bone to grow from the endplates through the implant for fusion as stated in para. 0045);
Placing an image of the second contact surface area on the radiodensity scan of the endplate (see para. 0076, which refers to radiodensity images; see paras. 0095, which refers to the use of virtual models, procedures, surgical plans, implants, graphics and/or images; see para. 0098, which refers to manipulating an image and adding a virtual implant to the image);
Determining a Hounsfield Unit score of the endplate (see para. 0076, which refers to voxels rendered in Hounsfield units for bone density) that correlates to a Hounsfield Parameter value based on the given area of the vertebra location that determined the Hounsfield Unit score for the second implant (see para. 0076, which refers to voxels rendered in Hounsfield units for bone density and the differences in the voxels between cortical and cancellous tissue; see para. 0079, which refers to using the Hounsfield units to select the implant and selecting the implant to avoid subsidence; note that because Casey’s goal is to avoid subsidence, it is apparent that there is a calculation of the Hounsfield Parameter value, which the Examiner is interpreting to be calculated by the computer);
Selecting either the first or second implant based on the Hounsfield Parameter value of between −5.0 and 8.0 (see para. 0079, which refers to using the Hounsfield units to select the implant and selecting the implant to avoid subsidence; note that because Casey’s goal is to avoid subsidence, it is apparent that the Hounsfield Parameter value, which the Examiner is interpreting to be calculated by the computer, would be between -5.0 and 8.0 as para. 0068 of Applicant’s disclosure states that -5.0 to 0.5 has a low risk of subsidence and 0.5 to 8.0 has a medium risk of subsidence – because Casey’s goal is to avoid subsidence, it is apparent that the range would not include 8.0 to 250 as such is identified by Applicant in para. 0068 as a high-risk region); and
Confirming that the superior and inferior central openings of the selected implant are adequate to permit fusion (see para. 0045, which refers to apertures 82 configured to allow bone to grow from the endplates through the implant for fusion).
Claim 20. Casey discloses wherein the second implant is selected so that the second contact area of the second implant is substantially the same as the first contact area of the first implant (see para. 0070, which states that the implants have different dimensions corresponding to the vertebral level).
Allowable Subject Matter
Claim 19 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant's arguments filed January 16, 2026 have been fully considered but they are not persuasive.
Applicant argues that Casey fails to calculate the Hounsfield Parameter value as recited in claim 12 (see pg. 11). The Examiner disagrees. A Hounsfield Parameter value is not a value that is based on a calculation that is known in the art. Instead, Applicant seems to be referring to a specific calculation performed using the equation on pg. 17 of the specification. However, the claim does not require the use of any particular equation. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). In addition, as stated in the rejection, it is apparent that there is a calculation of some Hounsfield Parameter value by the computer in order for the computer to use the Hounsfield units to select a desired implant to avoid subsidence.
Applicant also argues that it is improper to cite to Applicant’s disclosure to reject the claims (see pg. 11). The Examiner disagrees. It is permissible to cite to the disclosure when the disclosure identifies prior art or when the disclosure presents a fact. In the instant case, the Hounsfield Parameter value ranges identified in para. 0068 are presented as a fact in that low-risk correlates to -5.0 to 0.5, medium-risk correlates to 0.5 to 8.0, and high-risk correlates to 8.0 to 250. As stated in the rejection, Casey uses Hounsfield units to choose a particular implant in order to avoid subsidence. It logically follows that Casey would not choose an implant that would result in a high-risk of subsidence, and thus the implant chosen by Casey would be one having a low or medium risk of subsidence.
Thus, Casey though Casey may fail to explicitly disclose all of the steps present in claim 12, Casey inherently does so.
In order to overcome the rejection of claim 12, the Examiner suggests amending claim 12 as follows:
12. A method for selecting a spinal fusion implant for insertion between the endplates of adjacent vertebrae comprising the steps of:
Obtaining a radiodensity scan of the endplate of either vertebra of the vertebrae to contact the implant;
Selecting a proposed implant having a superior central opening and an inferior central opening;
Placing an image of the contact surface area of the implant on the radiodensity scan of the endplate;
[AltContent: textbox (HP =)][AltContent: textbox (ROIn+1 + 1000)][AltContent: textbox ([()][AltContent: connector][AltContent: textbox ())][AltContent: textbox (Arean+1)][AltContent: textbox (-)][AltContent: textbox (()][AltContent: textbox (ROIn + 1000)][AltContent: connector][AltContent: textbox (Arean)][AltContent: textbox ()])][AltContent: textbox (2)]Determining a Hounsfield Unit score of the endplate and determining a Hounsfield Parameter (HP) value based on the given area of the vertebra location that determined the Hounsfield Unit score; wherein
Selecting to use the implant if the Hounsfield Parameter value is between about -5.0 and 8.0.
Note that amending claim 12 as suggested above would result in the allowability of claim 12 as Casey does not disclose determining a Hounsfield Parameter value based on the particular equation presented in Applicant’s specification. Furthermore, amending claims 14 and 18 in a similar manner would result in the allowability of those claims.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JULIANNA N HARVEY whose telephone number is (571)270-3815. The examiner can normally be reached Mon.-Fri. 8:00am-5:00pm EST.
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/JULIANNA N HARVEY/Primary Examiner, Art Unit 3773