DETAILED ACTION
This action is in response to applicant’s amendment received on November 18th, 2025.
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.
Claims 1-5 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Beger (U.S. Publication 2017/0340367) in view of Isaacs (U.S. Patent 11,931,795).
Beger discloses a device (for example see Figure 1) comprising:
(claim 1) a flexible rod (12 and paragraph 19) configured to be manipulated to a bent state
(claim 5) wherein the flexible rod is made from a malleable material (paragraph 21)
(claim 1) a bending instructions generation subsystem including
(claim 1) an image capture device (52)
(claim 1) memory
(claim 1) a processor (48) in communication with the memory configured to
(claim 1) receive at least two images of the flexible rod in the bent state captured by the image capture device (for example see paragraphs 50-56)
(claim 1) generate a digital three dimensional representation of the flexible rod in the bent state based on the at least two images (for example see paragraph 39)
(claim 8) wherein the processor is configured to generate the digital three dimensional representation based on three or more images via a photogrammetry method (for example see paragraphs 16, 22, 23, and 50-54)
(claim 1) receive adjustment information that adjusts the digital three dimensional representative of the flexible rod to an adjusted shape (for example see paragraphs 59, 61, and 64-66)
(claim 1) generate bending instructions for bending a spinal rod so that it substantially conforms to the adjusted shape of the digital three dimensional representation (for example see paragraphs 35-36, 59, 61, and 64-66)
(claim 1) a bending tool (paragraph 66) configured to enable a user to bend a straight spinal rod according to the generated bending instructions
(claim 2) a fixture (16 and 18) configured to maintain a positioning of the flexible rod while the image capturing device captures the at least two images of the flexible rod in the bent state
(claim 3) wherein the flexible rod extends within a plane perpendicular to a base of the fixture when maintained by the fixture (see Figure 1)
(claim 4) wherein the fixture includes a fiducial marker and the marker is captured in the at least two images of the flexible rod
Beger fails to disclose the device wherein the processor is configured to receive adjustment information from a user interface and wherein the bending instructions are based on the adjusted digital three-dimensional representation. Isaacs teaches a device comprising a flexible rod, a bending instructions generation subsystem including an image capture device, a memory, and a processor, wherein the processor is capable of receiving adjustment information from a user interface (for example see column 22 lines 10-18 and column 24 lines 4-41) and wherein the bending tool is configured to receive bending instructions based on the adjustment information from the user information (column 24 lines 24-41) in order to allow a surgeon to impart a predetermined correction to a curvature of a spine (column 24 lines 10-12). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide the device of Beger wherein the processor is configured to receive adjustment information from a user interface and wherein the bending instructions are based on the adjusted digital three-dimensional representation in view of Isaacs in order to allow a surgeon to impart a predetermined correction to a curvature of a spine.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Beger (U.S. Publication 2017/0340367) in view of Isaacs (U.S. Patent 11,931,795) further in view of Morrison (U.S. Publication 2010/0268119).
The device of Beger as modified by Isaacs discloses the invention as claimed, see above, except for the device wherein the flexible rod is constructed of a material capable of transitioning from malleable to rigid upon a transitioning event. Morrison teaches a device comprising a flexible rod, wherein the rod is made from a material, such as PEEK, wherein the material is capable of transitioning from malleable to rigid upon a transitioning event (paragraph 16). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide the device of Beger as modified by Isaacs wherein the flexible rod is made from a material capable of transitioning from malleable to rigid upon a transitioning event, such as PEEK, in view of Morrison, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Beger (U.S. Publication 2017/0340367) in view of Isaacs (U.S. Patent 11,931,795) further in view of Weiser (U.S. Publication 2024/0058064).
The device of Beger as modified by Isaacs discloses the invention as claimed, see above, except for the image capture device being configured to capture video and the processor being configured to generate the digital three dimensional representation from the video. Weiser teaches a device comprising a flexible rod, a processor, and an image capture device, wherein the image capture device is configured to record video and the processor is capable of creating a digital three dimensional representation of a spinal rod based on the video (for example see paragraphs 55, 111, 112, 189, 190, 193, and 195; the camera for the augmented reality device videos the rod in real time and adjusts the proposed digital rod model based on the position of the screws and patient anatomy) in order to provide more accurate information of the flexible rod to the surgeon. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide the device of Beger as modified by Isaacs wherein the image capture device being configured to capture video and the processor being configured to generate the digital three dimensional representation from the video in view of Weiser in order to provide more accurate information of the flexible rod to the surgeon.
Response to Arguments
Applicant's arguments filed November 18th, 2025 have been fully considered but they are not persuasive. The applicant’s arguments are directed to the new limitations added in the amendment which are discussed above in the new grounds of rejection provided by the examiner.
Allowable Subject Matter
Claims 10-15 are allowed.
The following is an examiner’s statement of reasons for allowance:
Regarding claim 10:
Beger (U.S. Publication 2017/0340367) discloses a method comprising:
(claim 10) aligning a flexible rod with a plurality of screws installed in a patient (see Figure 1)
(claim 10) capturing at least two images of the aligned flexible rod via an image capture device
(claim 10) generate a digital three dimensional representation of the aligned flexible rod via a bending instructions generation subsystem based on the at least two captured images
Beger fails to disclose the step wherein aligning the flexible rod includes bending the flexible rod to conform to a path of the plurality of screws (the disclosure states the flexible rod could be a trial, but the disclosure never expands on how a trial would be used in the method, i.e. conforming the trial to the screws, generating a model of the trial, and using the model to bend a spinal rod to fit the screws, instead the method disclosed aligning the actual spinal rod and using the images to create a model to bend the actual spinal rod to fit the screws), adjusting the digital three dimensional representation of the aligned flexible rod with a user interface of the bending instructions generation subsystem, and bending a spinal rod using a bending tool according to the bending instructions generated by the bending instructions generation subsystem based on the adjusted digital three dimensional representation. U.S. Patent 11,931,795 (Isaacs) teaches a method including the step of using a user interface to adjust a digital three dimensional representation of an aligned flexible rod (see abstract and column 22 lines 9-18). The examiner was unable to find a reference or a combination of references that disclose and/or teach the limitations of claim 10 as presented.
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 Nicholas Woodall whose telephone number is (571) 272-5204. The examiner can normally be reached on Monday-Friday 8am to 5:30pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Kevin Truong, at (571. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NICHOLAS W WOODALL/Primary Examiner, Art Unit 3775