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 .
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 10, 13 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
With regards to claim 1 a new rejection was made with Redmon in view of Wiki (see rejection below). Likewise, see the other NPL cited in the PTO-892 as well as the video found in https://www.youtube.com/watch?v=UvevHXITVG4 (Translation Matrix - Interactive 3D Graphics from the channel Udacity), where mathematical matrices are widely known in the field of computer graphics to perform transformations to 3D objects in virtual space.
With regards to claims 10, 13, upon additional review of Redmon, new interpretations, not previously considered, are made. See rejections below. The examiner notes that for Claims 10, 13, the claims require that the flexible surgical sensor is configured to measure “at least one of” three options and that the claim does not require the measurements of two or three options. Likewise, Claims 10, 13 also claims that the display is configured to display an overlay “of one or more of” seven options and that the claim does not require the display to show two, three, four, five, six or all seven of the options. See PTO-892 for art of cited interest, in particular the following references disclose a display that shows the anatomy and virtual rods/instrumentation superimposed thereon, Stad US 2013/0345757 (paragraphs 33-34), Roger US 2019/0262083 (Figs 8-10, claims 34-46), Calloway US 2021/0169605 (Fig 7, 15-24 paragraph 50, 15,0, 152), Lovell US 2025/0049476 (Figs 1-12, paragraph 7, 10, 62), Weiser US 2024/0058064 (paragraph 16, 205).
Applicant is welcome to contact the examiner if they have any questions but examiner notes that a Power of Attorney was not filed, it is suggested to file one.
Claim Rejections - 35 USC § 102
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 10-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Redmond US 2016/0175013.
Regarding Claim 10, Redmon discloses a method for spinal surgery (paragraph 48) comprising:
receiving a planned rod contour (#80, Fig 4a-4b, paragraph 46 “line 80 which represents the final desired configuration of the spinal rod 70”);
using a flexible surgical sensor (#62, paragraph 46) to generate at least one of a first three-dimensional path (#62a, Fig 4a, paragraph 46 , “a sensor image line 62a which reflects the shape of the fiber optic shape sensor 62” and see paragraph 53 where the fiber optic is placed on implanted pedicle screws and thus generating a first 3D path), a second three-dimensional path, and a spinal contour of a patient;
using a display device (#52, Fig 1, 4a-4b) to display an overlay of one or more of:
the first three-dimensional path with the planned rod contour (as seen in Fig 4a, paragraph 46);
the planned rod contour with the spinal contour; the first three-dimensional path with the spinal contour;
the first three-dimensional path with a second three-dimensional path;
a surgical implement with the spinal contour;
the surgical implement with the first three-dimensional path; and
the surgical implement with the planned rod contour; and
generating a modified contour based on at least one of the planned contour (paragraph 46 “Using the controller 40, the fiber optic shape sensor 62 and the interrogator 60, the bender 62 is operated to automatically bend the spinal rod 70 to a desired shape” where based on the first 3D path #62a and the planned rod contour #80, a modified contour of the is generated so that the bender knows how to bend the rod #70), the first three dimensional path, the second three dimensional path, the spinal contour, and the overlay.
Regarding Claim 11, Redmon discloses bending a spinal rod according to the modified contour (via bender #62, paragraph 46 and discussed at the end of claim 10 above).
Regarding Claim 12, Redmon discloses the flexible surgical sensor is received by one or more pedicle screws (paragraph 53 “situated to engage the installed pedicle screws in-situ”) to facilitate conformity of the flexible surgical sensor with the spinal contour (paragraph 53).
Claims 13-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Redmond US 2016/0175013.
Regarding Claims 13, 15, 16, Redmond discloses a system (Fig 1-2) for facilitating spinal surgery comprising:
a non-transitory computer-readable storage medium (memory #52, Fig 2, paragraph 46) configured to store a planned rod contour (#80, paragraph 46, Fig 4a);
a flexible surgical sensor (#62) configured to measure at least one of:
a spinal contour of a patient, (Claim 15) the spinal contour of the patient is a current spinal contour of the patient // (Claim 16) the spinal contour of the patient is a desired spinal contour of the patient,
a first three-dimensional path (#62a, Fig 4a, paragraph 46, #62a, Fig 4a, paragraph 46, “a sensor image line 62a which reflects the shape of the fiber optic shape sensor 62” and see also paragraph 53 where the fiber optic is placed on implanted pedicle screws and thus able to create a first 3d path), and
a second three-dimensional path; and
a display device (display #52, Fig 2) configured to display an overlay of one or more of;
the first three-dimensional path with the planned rod contour (as seen in Fig 4a, paragraph 46);
the planned rod contour with the spinal contour;
the first three-dimensional path with the spinal contour;
the first three-dimensional path with a second three-dimensional path;
a surgical implement with the spinal contour; the surgical implement with the first three-dimensional path; and
the surgical implement with the planned rod contour.
The examiner notes that “a spinal contour of a patient” recited in Claim 13 line 4 is one of three options for the flexible surgical sensor to measure and claims 15, 16 further limit “spinal contour of a patient” option and Claim 15, 16 does not positively recite that the spinal contour has to be the option that is measured by flexible surgical sensor. Examiner notes that the device is
Regarding Claim 14, Redmond discloses a rod bender (bender #64) configured to bend a spinal rod according to the planned rod contour (paragraph 46).
Regarding Claim 17, Redmond discloses the non-transitory computer-readable storage medium (memory #52) is further configured to store data from the flexible surgical sensor (paragraph 46).
Regarding Claim 18, Redmond discloses the flexible surgical sensor (#62) is configured to be received by one or more pedicle screws to facilitate conformity of the flexible surgical sensor with the spinal contour (paragraph 49, 56, 63-64).
Regarding Claim 19, Redmond discloses a processor (CPU #51 which is part of computer #50, Fig 2) configured to receive adjustment parameters from a user, and based on the adjustment parameters, generate a modified contour (paragraph 43, 72, where manual input is possible).
Regarding Claim 20, Redmond discloses a processor (CPU #51 which is part of computer #50, Fig 2) configured to receive user modifications to the planned rod contour, and to modify the planned rod contour per the user modifications to generate a modified contour (paragraph 43, 72 where manual input from a user is possible).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 3-8 are rejected under 35 U.S.C. 103 as being unpatentable over Redmond US 2016/0175013 in view of Wiki (see NPL attached).
Regarding Claim 1, Redmond discloses a method for spinal surgery comprising:
receiving a planned rod contour (paragraph 48, especially the last sentence, where when planning and installing pedicle screws, there would be at least a planned contour for a spinal rod, Fig 4a-4b, where the planned contour is #80);
using a flexible surgical sensor (fiber optic sensor #62) to generate a three- dimensional path (#62a as seen in Fig 4a, paragraph 46), wherein the three-dimensional path represents a spinal contour of a patient (paragraph 47, 51, 53, flexible sensor #62 is placed on pedicle screws already implanted to determine the spinal contour of a patient, see also Figs 4a-4b where the depiction is in 3D); and
calculating a delta vector based on the three-dimensional path and the planned rod contour (paragraph 46, 51, “using the controller 40, the fiber optic shape sensor 62 and the interrogator 60, the bender 62 is operated to automatically bend the spinal rod 70 to a desired shape”, where the difference between the 3-d path #62a and the planned contour #80 is calculated, a delta vector, so that the sensor and bender 62 knows how to bend the rod accordingly);
generating a modified contour based on the delta vector and at least one of the planned rod contour and the three-dimensional path (paragraph 46, 51, “using the controller 40, the fiber optic shape sensor 62 and the interrogator 60, the bender 62 is operated to automatically bend the spinal rod 70 to a desired shape”, where the software/system of Redmond calculates a difference between the 3-d path #62a and the planned contour #80 is calculated, a delta vector, so that the system and bender #62 knows how to bend the rod accordingly); and
bending a spinal rod according to one of: the planned rod contour, the spinal contour of the patient, and the modified contour (end of paragraph 46 where bender #62 bend the rod based on the delta vector, discussed above).
Redmon does not disclose that a mathematical matrix is used to calculate the delta vector based on the three-dimensional path and the planned rod contour.
Wiki, pertinent to the problem of manipulating 3d objects in computer graphics, discloses using a mathematical matrix, such as a transformation matrix is widely used 3D computer graphics to transform a three-dimensional object (see “Uses” section, and “Examples in 2 dimensions” section and “Examples in 3d computer graphics” section where objects are transformed in 3d space).
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify Redmon to use mathematical matrix to calculate the delta vector because a mathematical matrix, such as transformation matrix in view of Wiki above because a linear transformation matrix is a widely known methodology used in 3d computer graphics to transform three dimensional objects in 3d space.
Regarding Claim 3, Redmond discloses the spinal contour of the patient is a current spinal contour of the patient (paragraph 53, flexible sensor #62 is placed on pedicle screws already implanted to determine the spinal contour of a patient).
Regarding Claim 4, Redmond discloses the spinal contour of the patient is a desired spinal contour of the patient (paragraph 49, 56, and see also paragraph 64 where flexible sensor #62 is placed on the pedicle screws and the surgeon also manipulates the patient to have a desired spinal contour such that the spinal contour generated by the flexible sensor is the desired spinal contour).
Regarding Claim 5, Redmond discloses the flexible surgical sensor is received by one or more pedicle screws to facilitate conformity of the flexible surgical sensor with the spinal contour (paragraph 53).
Regarding Claim 7, Redmond discloses the planned rod contour is divided into multiple spinal levels (paragraph 48, 62 where the planned contour spans over at least two spinal levels with the installation of at least two pedicle screws), wherein modifications are selected independently for each spinal level (paragraph 48, 49, 62, and also paragraph 63 where the flexible sensor #62 is in malleable template #70’ that is placed onto pedicle screws and the template #70’ adjusted/bent for as many times as needed to get the desired fit).
Regarding Claim 8, Redmond discloses adjusting the planned rod contour based on the spinal contour of the patient to generate the modified contour (paragraph 49, 64 where flexible sensor #62 is placed on the pedicle screws and the surgeon also manipulates the patient to have a desired spinal contour such that the spinal contour generated by the flexible sensor is the desired spinal contour).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Redmond US 2016/0175013 in view of Wiki (see NPL attached) as applied to claim 1 above, and further in view of Mariampillai US 2024/0390050.
Redmon as modified discloses the claimed invention as discussed above but does not disclose the method further comprises preoperatively generating the planned rod contour based on a desired spinal contour of the patient.
McClintock discloses a method for spinal surgery comprising:
receiving a planned rod contour (paragraph 74, “preoperatively-defined rod contour”); generate a three-dimensional path, wherein the three-dimensional path represents a spinal contour of a patient (paragraph 216 via touching the heads of screws); and bending a spinal rod according to one of: the planned rod contour, the spinal contour of the patient, and a modified contour derived from the planned rod contour and/or the spinal contour of the patient (paragraph 104, 162, 215). Regarding Claim 2, Mariampillai discloses the method further comprises preoperatively generating the planned rod contour based on a desired spinal contour of the patient (paragraph 74, 215) so that the surgeon has a plan for what the rod would be and what the desired outcome of the surgery would be prior to the start of the surgery (paragraph 74, 215).
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify Redmond as modified to preoperatively generate the planned rod contour based on a desired spinal contour of the patient in view of Mariampillai above so that the surgeon has a plan for what the rod would be and what the desired outcome of the surgery would be prior to the start of the surgery.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAN CHRISTOPHER L MERENE whose telephone number is (571)270-5032. The examiner can normally be reached Mon-Fri 8:30 am - 6pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eduardo Robert can be reached at 571-272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAN CHRISTOPHER L MERENE/ Primary Examiner, Art Unit 3773