DETAILED ACTION
This action is in response to applicant’s amendment received on August 26th, 2026.
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 1-13 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Roy (U.S. Publication 2002/0049394) in view of Navarro (U.S. Publication 2005/0273170).
Roy discloses a device (for example see Figure 18) comprising:
(claim 1) a spinal cage including
(claim 1) a body (920)
(claim 1) wherein the body is configured to be implanted in an intervertebral space
(claim 1) the body including
(claim 1) an opening (the opening that receives element 932) at a first end of the body
(claim 1) a cavity (interior chamber; paragraph 92)
(claim 1) wherein the cavity extends from the opening to a second end of the body
(claim 1) at least one sensor (42; paragraph 94) within the cavity
(claim 1) wherein the at least one sensor is configured to generate date
(claim 5) wherein the at least one sensor is a pressure sensor
(claim 8) wherein the at least one sensor is a strain gauge (940)
(claim 1) a processor (950; 950 is within the cavity when element 932 is attached to the body; Figure 18 shows 950 including the processor)
(claim 1) wherein the process is physically housed inside the cavity of the body (element 950 is housed within the cavity when element 932 is attached to the body)
(claim 1) wherein the processor is electrically coupled to the at least one sensor
(claim 1) wherein the processor is configured to collect data generated by the at least one sensor (paragraph 95)
(claim 1) an antenna (970; paragraph 95)
Roy further discloses a method of using the device comprising:
(claim 1) providing the device discussed above
(claim 1) the at least one sensor generating data indicative of one or more of a fixation/fusion state of the device (paragraph 96; the fixation of the device directly corresponds to the fusion of the device)
(claim 1) the antenna transmitting the data to a remote location (for example see paragraphs 58, 59, and 95)
(claims 1 and 9) periodically receiving data generated by the at least one sensor (paragraph 96; continuously or on-demand assessments are periodically)
(claims 1 and 9) processing the data as a function of time to determine a change on the spinal cage (for example see paragraph 62; data generated continuously provides data points over time and the display of the data would be a function of changes over time)
(claim 1) wherein the change is indicative of a change in the fixation/fusion of the spinal cage (for example see paragraph 66)
(claim 9) wherein the change is a change of force on the device
(claim 13) wherein the change in force/pressure is indicative of a change in the fixation/fusion of the device in the intervertebral space (paragraph 96)
(claim 15) wherein the change is a change in strain on the device over time indicative of a change in the fixation/fusion of the device in the intervertebral space
Roy fails to disclose the device wherein the at least one sensor, i.e. the pressure sensor, includes a position sensor, a vibration sensor, a contact sensor, or an accelerometer. Navarro teaches a device comprising a spinal implant including a body and at least one sensor that includes a pressure sensor (see paragraph 35) and a combination of other sensors (for example see paragraphs 35 and 72) including a position sensor (claim 2; paragraph 72) to generate data of the position of the device, a vibration sensor to generate data of vibration of the device (claim 3; see paragraph 72), a contact sensor to generate data of the contact of the device (claim 4; see paragraph 72), and/or an accelerometer to measure movement, such as tilt and/or rotation, of the device (claims 6-7; paragraphs 35 and 72) in order to generate date relative to the implant during use. 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 Roy wherein the at least one sensor further includes a position sensor, a vibration sensor, a contact sensor, and/or an accelerometer in view of Navarro in order to generate data relative to the implant during use.
The invention of Roy as modified by Navarro discloses a method of using the device wherein the at least one sensor periodically generates data over time based on the at least one sensor to determine a change in movement, such as rotation and/or tilt, of the spinal cage over time relative to a change of fixation/fusion, a change in contact between the spinal cage and tissue over time, and/or a change in force on the spinal cage over time indicative of the change in fixation and/or fusion of the device during use (claims 1 and 9-12; for example see paragraph 66).
Response to Arguments
Applicant's arguments filed August 26th, 2026 have been fully considered but they are not persuasive. The applicant’s arguments are directed to the amendments to the claims which are discussed in the new grounds of rejection provided above.
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
