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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 4/13/2026 has been entered.
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.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: “the flexible sensor is configured to independently measure each of the multiple spinal levels” in claim 13 was not disclosed in the original specification.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 13-25 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 13 discloses “the flexible sensor is configured to independently measure each of the multiple spinal levels” which was not disclosed in the original specification. Paragraphs 13, 56 discloses modifications for each spinal level may be done “independently” but does not disclose measurements from the flexible sensor are taken independently.
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 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Redmond US 2016/0175013 in view of Linares US 2018/0000522.
Regarding Claim 10, Redmond 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”);
inserting and positioning the flexible surgical sensor (#62, paragraph 46) within a surgical site so that the flexible surgical sensor spans multiple spinal levels (paragraph 53 where the fiber optic is placed on implanted pedicle screws which spans across multiple spinal levels).
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, Redmond 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, Redmond 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).
Redmond discloses that the display can be a touch screen (paragraph 42) and
each vertebral level is unique such that “the pedicle screws may vary in insertion position, insertion angle, and insertion depth from vertebra to vertebra” (paragraph 48) but does not disclose dividing the planned rod contour into multiple plan portions that correspond to the multiple spinal levels; using the display device to modify the multiple plan portions independently for each of the multiple spinal levels.
Linares teaches the use of a spinal rod (#50 and/or #52) for spanning multiple spinal levels (as seen in Fig 4), dividing the planned rod contour of the spinal rod into multiple plan portions that correspond to the multiple spinal levels (the bend or contour of the rod takes into account each vertebral level to ensure that that there is no undesirable bone on bone contract locations between each vertebra, paragraph 46); modifying one or more of the multiple plan portions independently based on each of the multiple path portions (paragraph 46, where each vertebral level for a particular patient is unique and thus each level is considered and the rod modified accordingly to avoid undesirable bone on bone contract of the rod between each vertebra).
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 divide the planned rod contour into multiple plan portions that correspond to the multiple spinal levels; use the display device to modify the multiple plan portions independently for each of the multiple spinal levels in view of Linares above since each vertebra level is unique and this avoids undesirable bone on bone contract of the rod between each vertebra.
As such Redmond as modified discloses: dividing the planned rod contour into multiple plan portions (the planned rod contour would be divided to correspond to each individual spinal level to ensure that each divided portion of the rod contour avoid undesirable bone contact as discussed in Linares above) that correspond to the multiple spinal levels (each individual spinal level collectively corresponds to the multiple spinal levels); use the display device to modify the multiple plan portions independently for each of the multiple spinal levels (each plan portion would be modified accordingly to ensure that the rod avoids undesirable bone contact as discussed in Linares above, paragraph 42, 72 in Redmond where the display can be a touch screen and where modifications can be manually inputted).
Claims 13-20 are rejected under 35 U.S.C. 103 as being unpatentable over Redmond US 2016/0175013 in view of Linares US 2018/0000522.
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,
wherein:
the flexible surgical sensor is configured to span multiple spinal levels (paragraph 53 where the fiber optic is placed on implanted pedicle screws which spans across multiple spinal levels);
the flexible sensor is configured to independently measure each of the multiple spinal level (examiner notes that this limitation is intended use and see paragraph 47, 51, 53 where the flexible sensor 62 is able to be placed only in one spinal level such that each level can be independently measured).
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.
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).
Regarding Claim 21, Redmond discloses the flexible surgical sensor comprises a passive surgical sensor that does not include any active sensor components (“optical shape sensor” paragraph 9, 39 which are passive and do not emit energy); and the system further comprises one or more sensor fields configured to detect properties of the passive surgical sensor to generate a 3D path to provide the spinal contour (end of paragraph 47 where the display is connected to one or more sensor fields to display the 3D shape in various views), the first three-dimensional path, or the second three-dimensional path.
Redmond discloses that the display can be a touch screen where modifications can be manually inputted (paragraph 42, 72) and each vertebral level is unique such that “the pedicle screws may vary in insertion position, insertion angle, and insertion depth from vertebra to vertebra” (paragraph 48) but does not disclose the display device is configured to facilitate modification of the planned contour independently for each spinal level.
Linares teaches the use of a spinal rod (#50 and/or #52) for spanning multiple spinal levels (as seen in Fig 4), where each vertebral level for a particular patient is unique and thus each level is considered and the rod modified accordingly to avoid undesirable bone on bone contract of the rod between each vertebra (paragraph 46).
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 for the display device to be configured to facilitate modification of the planned contour independently for each spinal level in view of Linares above since each vertebra level is unique and avoids undesirable bone on bone contract of the rod between each vertebra. Examiner notes that since the display is a touch screen, it can be used to provide modifications to ensure that there is no undesirable bone on bone contract of the rod between each vertebra.
Regarding Claim 22, Redmond discloses the claimed invention as discussed above where the one or more sensor fields allows for viewing the 3d shape of the rod in various views (end of paragraph 47) but does not disclose the one or more sensor fields comprises a first sensor field comprising one of a transverse plane, a mid-sagittal, and a parasagittal plane.
As such, 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 have a first sensor field comprising one of a transverse plane, a mid-sagittal, and a parasagittal plane in order to view the rod in various views and perspectives.
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 previously attached) and Linares US 2018/0000522.
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);
inserting and positioning a flexible surgical sensor (fiber optic sensor #62) within a surgical site so that the flexible surgical sensor spans multiple spinal levels (paragraph 47, 51, 53, flexible sensor #62 is placed on pedicle screws, already implanted across multiple spinal levels, to determine the spinal contour of a patient)
using the 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).
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).
Redmond 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.
Redmond each vertebral level is unique such that “the pedicle screws may vary in insertion position, insertion angle, and insertion depth from vertebra to vertebra” (paragraph 48) but does not disclose dividing the planned rod contour into multiple plan portions that correspond to the multiple spinal levels; dividing the three-dimensional path into multiple path portions that correspond to the multiple spinal levels; modifying one or more of the multiple plan portions independently based on each of the multiple path portions.
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).
Linares teaches the use of a spinal rod (#50 and/or #52) for spanning multiple spinal levels (as seen in Fig 4), dividing the planned rod contour of the spinal rod into multiple plan portions that correspond to the multiple spinal levels (the bend or contour of the rod takes into account each vertebral level to ensure that that there is no undesirable bone on bone contract locations between each vertebra, paragraph 46); modifying one or more of the multiple plan portions independently based on each of the multiple path portions (paragraph 46, where each vertebral level for a particular patient is unique and thus each level is considered and the rod modified accordingly to avoid undesirable bone on bone contract of the rod between each vertebra).
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 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.
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 divide the planned rod contour into multiple plan portions (each individual spinal level) that correspond to the multiple spinal levels; divide the three-dimensional path into multiple path portions that correspond to the multiple spinal levels; divide one or more of the multiple plan portions independently based on each of the multiple path portions in view of Linares above since each vertebra level is unique and avoid undesirable bone on bone contract of the rod between each vertebra.
As such Redmond as modified discloses: dividing the planned rod contour into multiple plan portions (the planned rod contour would be divided to correspond to each individual spinal level to ensure that each divided portion of the rod contour avoid undesirable bone contact as discussed in Linares above) that correspond to the multiple spinal levels (each individual spinal level collectively corresponds to the multiple spinal levels); dividing the three-dimensional path into multiple path portions that correspond to the multiple spinal levels (the 3d path would be divided to correspond to each individual spinal level to ensure the rod avoids undesirable bone contact as discussed in Linares above); modifying one or more of the multiple plan portions independently based on each of the multiple path portions (each plan portion would be modified accordingly to ensure that the rod avoids undesirable bone contact as discussed in Linares above). [Examiner notes that the claims as well as the specification does not disclose how the planned rod contour is divided and what specific modifications is being made.]
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) and Linares US 2018/0000522 as applied to claim 1 above, and further in view of Mariampillai US 2024/0390050.
Redmond 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
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
