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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 August 11, 2025 has been entered.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 4-6, 11-13, 16, 25, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. PG Pub. No. 2008/0269596 A1 to Revie et al., in view of U.S. Patent No. 6,516,213 B1 to Nevo, and in view of U.S. PG Pub. No. 2019/0388105 A1 to Sharma et al.
Regarding claims 1 and 25, Revie discloses a guided orthopedic surgery method comprising: securing a plurality of tags to an anatomical feature of a subject, measuring, with the respective surgical tag at a first time, a respective initial measurement at a respective first position of each surgical tag; measuring, with the respective surgical tag at a second time, a respective subsequent measurement at a respective second position of each surgical tag; and determining, with the computer and using the respective initial and subsequent measured magnitudes, a respective relative first position and a respective relative second position of each surgical tag along the axis (see Figs. 5, 6, 23, 27, and 34 and para 16, 18, 19, 191-195, and 341).
Nevo discloses a similar surgical tracking method, providing magnetically-sensitive surgical tags including: a respective magnetic sensor; and a respective data transmitter in electrical communication with the respective magnetic sensor; producing, with one or more magnetic field gradient coil(s), a magnetic field having a magnetic field gradient with respect to an axis; measuring, with the respective magnetic sensor of each magnetically-sensitive surgical tag at a first time, a respective initial measured magnitude of the magnetic field at a respective first position of each magnetically-sensitive surgical tag; transmitting, with the respective data transmitter, the respective initial measured magnitude from each magnetically-sensitive surgical tag to a computer; measuring, with the respective magnetic sensor of each magnetically-sensitive surgical tag at a second time, a respective subsequent measured magnitude of the magnetic field at a respective second position of each magnetically-sensitive surgical tag; transmitting, with the respective data transmitter, the respective subsequent measured magnitude from each magnetically-sensitive surgical tag to the computer; and
determining, with the computer and using the respective initial and subsequent measured magnitudes, a respective relative first position and a respective relative second position of each magnetically-sensitive surgical tag along the axis, the respective relative first position and the respective relative second position measured with respect to the one or more magnetic field gradient coil(s) (see entire document, noting particularly cols 5-7 and Figs. 1, 2, 4, 6, and 7).
It would have been obvious and predictable to have substituted the tracking system of Revie for the similar tracking system of Nevo because doing so would provide the predictable and known output of tracking the surgical markers already in Revie for the purpose of carrying out the Revie method. Further, the Nevo tracking method provides advantages such as real-time 3D imaging as well as non-ionizing imaging that is compatible with many forms of imaging including X-ray and MRI.
Examiner notes that the combination of Nevo in view of Revie would also be obvious because doing so would use the tracking device of Nevo for the purpose of providing intra-operative quality control.
Sharma discloses a similar localization device, wherein a field is produced by planar magnetic field gradient RF coils that are vertically arranged in a gradient coil stack (see Figs. 6-8 and 28 and para 41 and 42).
It would have been a mere matter of obvious substation to have substituted one set of 3D gradient coils for another because either set of coils would produce the necessary field required by the Revie method.
Regarding claim 4, Nevo in combination with Revie discloses a method, wherein: the one or more magnetic field gradient coil(s) includes a first magnetic field gradient coil that produces a first magnetic field with respect to the first axis, the respective initial measured magnitude is a first initial measured magnitude, the respective subsequent measured magnitude is a first subsequent measured magnitude, and the method further comprises: producing, with at least a second magnetic field gradient coil, a second magnetic field having a second magnetic field gradient with respect to a second axis that is orthogonal to the first axis; measuring, with the respective magnetic sensor of each magnetically- sensitive surgical tag at a third time, a respective second initial measured magnitude of the second magnetic field at the respective first position of each magnetically-sensitive surgical tag; transmitting, with the respective data transmitter, the respective second initial measured magnitude from each magnetically-sensitive surgical tag to the computer; measuring, with the respective magnetic sensor of each magnetically- sensitive surgical tag at a fourth time, a respective second subsequent measured magnitude of the second magnetic field at the respective second position of each magnetically-sensitive surgical tag; and transmitting, with the respective data transmitter, the respective second subsequent measured magnitude from each magnetically-sensitive surgical tag to the computer (see Nevo entire document, noting particularly cols 5-7 and Figs. 1, 2, 4, 6, and 7 and Revie Figs. 5, 6, 23, 27, and 34 and para 16, 18, 19, 191-195, and 341). Examiner notes that claim 4 indicates that an additional orthogonal axis is measured at two times. Nevo discloses measuring all three orthogonal directions and Revie discloses measurements pre and post operation.
It would have been obvious and predictable to have substituted the tracking system of Revie for the similar tracking system of Nevo because doing so would provide the predictable and known output of tracking the surgical markers already in Revie for the purpose of carrying out the Revie method. Further, the Nevo tracking method provides advantages such as real-time 3D imaging as well as non-ionizing imaging that is compatible with many forms of imaging including X-ray and MRI.
Examiner notes that Sharma discloses and renders obvious stacked coils as noted for claim 1.
Regarding claim 5, Nevo in combination with Revie discloses a method, further comprising: producing, with at least a third magnetic field gradient coil, a third magnetic field having a third magnetic field gradient with respect to a third axis that is orthogonal to the first and second axes; measuring, with the respective magnetic sensor of each magnetically- sensitive surgical tag at a fifth time, a respective third initial measured magnitude of the third magnetic field at the respective first position of each magnetically-sensitive surgical tag; transmitting, with the respective data transmitter, the respective third initial measured magnitude from each magnetically-sensitive surgical tag to the computer; measuring, with the respective magnetic sensor of each magnetically- sensitive surgical tag at a sixth time, a respective third subsequent measured magnitude of the third magnetic field at the respective second position of each magnetically-sensitive surgical tag; and transmitting, with the respective data transmitter, the respective third subsequent measured magnitude from each magnetically-sensitive surgical tag to the computer (see Nevo entire document, noting particularly cols 5-7 and Figs. 1, 2, 4, 6, and 7 and Revie Figs. 5, 6, 23, 27, and 34 and para 16, 18, 19, 191-195, and 341). Examiner notes that claim 5 indicates that an additional orthogonal axis is measured at two times. Nevo discloses measuring all three orthogonal directions and Revie discloses measurements pre and post operation.
It would have been obvious and predictable to have substituted the tracking system of Revie for the similar tracking system of Nevo because doing so would provide the predictable and known output of tracking the surgical markers already in Revie for the purpose of carrying out the Revie method. Further, the Nevo tracking method provides advantages such as real-time 3D imaging as well as non-ionizing imaging that is compatible with many forms of imaging including X-ray and MRI.
Examiner notes that Sharma discloses and renders obvious stacked coils as noted for claim 1.
Regarding claim 6, Nevo in combination with Revie discloses a method, further comprising displaying the respective relative first, second, and third pre-surgical positions and the respective relative first, second, and third post-surgical positions of each magnetically-sensitive surgical tag on a display operatively coupled to the computer (see Nevo entire document, noting particularly cols 5-7 and Figs. 1, 2, 4, 6, and 7 and Revie Figs. 5, 6, 23, 27, and 34 and para 16, 18, 19, 191-195, and 341). Examiner notes that claim 6 indicates that all three orthogonal directions are measured at two times. Nevo discloses measuring all three orthogonal directions and Revie discloses measurements pre and post operation.
It would have been obvious and predictable to have substituted the tracking system of Revie for the similar tracking system of Nevo because doing so would provide the predictable and known output of tracking the surgical markers already in Revie for the purpose of carrying out the Revie method. Further, the Nevo tracking method provides advantages such as real-time 3D imaging as well as non-ionizing imaging that is compatible with many forms of imaging including X-ray and MRI.
Regarding claim 11, Revie discloses a method, further comprising performing one or more surgical steps between the first time and the second time (see Figs. 5, 6, 23, 27, and 34 and para 16, 18, 19, 191-195, and 341).
Regarding claim 12, Revie discloses a method, wherein the one or more surgical steps comprises at least a portion of a total hip replacement surgery (see para 161, 196, and 277).
Regarding claim 13, both Revie and Nevo disclose a method, further comprising, with each magnetically- sensitive surgical tag, wirelessly transmitting the respective initial measured magnitude and the respective subsequent measured magnitude from the respective magnetic sensor to the respective data transmitter (see Revie Fig. 9 and para 207 and Nevo col 13 ln 19-37).
It would have been obvious and predictable to have used wireless transmission to eliminate the cumbersome use of wires that may get in the way of the surgeon.
Regarding claim 16, Revie discloses a method, wherein: at least one of the magnetically-sensitive surgical tags is attached to a surgical screw, and securing the at least one of the magnetically-sensitive surgical tags to an anatomical feature of the subject comprises driving the surgical screw into a bone of the subject (see Fig. 9 and para 207).
Regarding claim, 26 Revie discloses a method and device, wherein: the gradient-coil stack is disposed in a gradient-coil pad, and the method further comprises placing the gradient-coil pad on or in a bed of the subject (see Fig. 14 and para 231-233, noting that Sharma already discloses the stacked gradient coils as noted with respect to claim 1).
Claims 2, 3, 7, and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Revie, Nevo, and Sharma as applied to claims 1 and 5 above, and further in view of either or both of U.S. PG Pub. No. 2017/0281283 A1 to Siegler et al. and U.S. PG Pub. No. 2021/0128250 A1 to Chav.
Regarding claim 2, Revie discloses comparing tracking data but does not disclose the below noted threshold comparison.
However, Siegler and Chav disclose similar surgical tracking methods, further comprising: comparing, in the computer, the respective relative first position and the respective relative second position of each magnetically-sensitive surgical tag; when a difference between the respective relative first position and the respective relative second position is within a threshold distance, indicating, with the computer, that the respective relative first position and the respective relative second position are the same; and when the difference between the respective relative first position and the respective relative second position is greater than the threshold distance, indicating, with the computer, that the respective relative first position and the respective relative second position are different (see Siegler Fig. 20 and para 199 and Chav para 18 and 104).
It would have been obvious and predictable to have combined the teachings of Revie and either or both of Siegler and Chav because doing so would alert a user to changes to the surgical scene over time.
Regarding claim 3, Revie discloses comparing tracking data but does not disclose the below noted comparison.
However, Siegler and Chav disclose similar surgical tracking methods, further comprising: comparing, in the computer, the respective relative first position and the respective relative second position of each magnetically-sensitive surgical tag; when a difference between the respective relative first position and the respective relative second position is within a desired offset distance range, indicating, with the computer, that the respective relative first position and the respective relative second position are the same; and when the difference between the respective relative first position and the respective relative second position is outside of the desired offset distance range, indicating, with the computer, that the respective relative first position and the respective relative second position are different (see Siegler Fig. 20 and para 199 and Chav para 18 and 104).
It would have been obvious and predictable to have combined the teachings of Revie and either or both of Siegler and Chav because doing so would alert a user to changes to the surgical scene over time.
Regarding claim 7, Revie discloses comparing tracking data but does not disclose the below noted comparison.
However, Siegler and Chav disclose similar surgical tracking methods, further comprising: comparing, in the computer, a respective first three-dimensional relative position of each magnetically-sensitive surgical tag with a respective second three- dimensional relative position of each magnetically-sensitive surgical tag, wherein: the respective first three-dimensional relative position comprises the respective relative first, second, and third initial positions of each magnetically- sensitive surgical tag, and the respective second three-dimensional relative position comprises the respective relative first, second, and third subsequent positions of each magnetically-sensitive surgical tag; when a difference between the respective first three-dimensional relative position and the respective second three-dimensional relative position is less than or equal to a threshold distance with respect to the first, second, or third axis, indicating, with the computer, that the respective first three-dimensional relative position and the respective second three-dimensional relative position are the same; and when the difference between the respective first three-dimensional relative position and the respective second three-dimensional relative position is greater than the threshold distance with respect to the first, second, or third axis, indicating, with the computer, that the respective first three-dimensional relative position and the respective second three-dimensional relative position are different (see Siegler Fig. 20 and para 199 and Chav para 18 and 104).
It would have been obvious and predictable to have combined the teachings of Revie and either or both of Siegler and Chav because doing so would alert a user to changes to the surgical scene over time.
Regarding claim 8, Revie discloses comparing tracking data but does not disclose the below noted comparison.
However, Siegler and Chav disclose similar surgical tracking methods, further comprising: comparing, in the computer, a respective first three-dimensional relative position of each magnetically-sensitive surgical tag with a respective second three- dimensional relative position of each magnetically-sensitive surgical tag, wherein: the respective first three-dimensional relative position comprises the respective relative first, second, and third initial positions of each magnetically- sensitive surgical tag, and the respective second three-dimensional relative position comprises the respective relative first, second, and third subsequent positions of each magnetically-sensitive surgical tag; when a straight-line distance between the respective first three-dimensional relative position and the respective second three-dimensional relative position is less than or equal to a threshold distance, indicating, with the computer, that the respective first three-dimensional relative position and the respective second three-dimensional relative position are the same; and when the straight-line distance between the respective first three-dimensional relative position and the respective second three-dimensional relative position is greater than the threshold distance, indicating, with the computer, that the respective first three-dimensional relative position and the respective second three-dimensional relative position are different (see Siegler Fig. 20 and para 199 and Chav para 18 and 104, noting a skilled artisan would consider the distance of the prior art a straight-line distance).
It would have been obvious and predictable to have combined the teachings of Revie and either or both of Siegler and Chav because doing so would alert a user to changes to the surgical scene over time.
Claims 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Revie, Nevo, Siegler, Sharma, and Chav as applied to claim 8 above, and further in view of U.S. PG Pub. No. 2020/0246088 A1 to Mewes et al.
Regarding claims 9 and 10, Mewes discloses a similar surgical tracking system, further comprising: adjusting the respective second three-dimensional relative position of at least one of the magnetically-sensitive surgical tags (see Fig. 3 and para 13-15 and 51-53).
It would have been obvious and predictable to have combined the teachings of Revie and Nevo with the further teachings of Mewes because doing so would predictably allow for line-of-sight problems to be remedied and would allow a user generally to move markers that are misplaced or that have been dislodged.
Further, Siegler and Chav discloses a similar method, further comprising after adjusting the respective second three-dimensional relative position of at least one of the magnetically-sensitive surgical tags, sequentially producing the first, second, and third magnetic fields, the first, second, and third magnetic fields having the first, second, and third magnetic field gradients, respectively; measuring, with the respective magnetic sensor of each magnetically-sensitive surgical tag, first, second, and third post-adjustment measured magnitudes of the first, second, and third magnetic fields, respectively, at a respective post-adjustment position of each magnetically-sensitive surgical tag; transmitting, with the respective data transmitter, the first, second, and third post-adjustment measured magnitudes from each magnetically-sensitive surgical tag to the computer; and determining, in the computer, a post-adjustment three-dimensional relative position of each magnetically-sensitive surgical tag based on the first, second, and third post-adjustment measured magnitudes; and wherein: the straight-line distance is an initial straight-line distance, and the method further comprises: when a subsequent straight-line distance between the respective first three- dimensional relative position and the post-adjustment three-dimensional relative position is less than or equal to the threshold distance, indicating, with the computer, that the respective first three-dimensional relative position and the post-adjustment three-dimensional relative position are the same; and when the straight-line distance between the respective first three-dimensional relative position and the post-adjustment three-dimensional relative position is greater than the threshold distance, indicating, with the computer, that the respective first three-dimensional relative position and the post-adjustment three-dimensional relative position are different (see Siegler Fig. 20 and para 199 and Chav para 18 and 104, Examiner notes that Mewes indicates that tracking updates should be made after moving a tracker and also that Chav discloses continuous tracking that reads on tracking after an adjustment).
It would have been obvious and predictable to have combined the teachings of Revie and either or both of Siegler and Chav because doing so would alert a user to changes to the surgical scene over time.
Claims 14 and 15 rejected under 35 U.S.C. 103 as being unpatentable over Revie, Nevo, and Sharma as applied to claim 1 above, and further in view of U.S. PG Pub. No. 2008/0122712 A1 to Chen.
Regarding claim 14, Revie discloses a method, wherein: the data transmitter comprises: a circuit; and a power and data management unit (PDMU) electrically coupled to the circuit and to the magnetic sensor, the PDMU configured to modulate circuit to transmit data to a radio-frequency (RF) coil that is operatively coupled to the computer, and the method further comprises: generating an RF electromagnetic field with the RF coil; and modulating circuit to transmit the respective initial measured magnitude and the respective subsequent measured magnitude (see para 223-227).
Further, Chen discloses a similar communications circuit, wherein the PDMU is configured to modulate an impedance of the LC circuit to transmit data to a radio-frequency (RF) coil that is operatively coupled to the computer, and the method further comprises: generating an RF electromagnetic field with the RF coil; and modulating the impedance of the LC circuit to transmit the respective initial measured magnitude and the respective subsequent measured magnitude (see para 5 and 8-11).
It would have been obvious and predictable to have modified the circuit of Revie with the teachings of Chen because doing so would predictably provide a tuned a transmitter/receiver pair for optimal data communication.
Regarding claim 15, Revie discloses a method, further comprising wirelessly delivering power to each magnetically-sensitive surgical tag with the RF electromagnetic field (see Figs. 9 and 11 and para 225, 227, and 232).
It would have been obvious and predictable to have used wireless inductive charging because doing so would reduce the need for changing batteries and eliminate the chance of a sensor running out of batteries during a procedure.
Response to Arguments
Applicant's arguments filed August 11, 2025 have been fully considered but they are not persuasive.
Applicant argues that Revie teaches against combination with Sharma because Revie teaches that coils should not be overlapping and that Sharma teaches overlapping coils.
Applicant’s remarks are unpersuasive because the coils of Sharma are not overlapping based on the teaching of Revie. As Applicant points out, Revie teaches, “so long as they are non-overlapping, that is, there are no two field generator coils with the exact, identical location and orientation.” Emphasis added by Examiner citing page 9 of the most recent response that cites to paragraph 210 of Revie. It is clear from Revie that the coils of Sharma must have the exact same location and orientation as each other to be non-overlapping and therefore contrary to combination with Revie. However, Applicant’s reading of Sharma is flawed. Sharma does not show overlapping coils because the coils of Sharma do not share the same location and/or orientation. Figure 8 cited by Examiner and reproduced by Applicant clearly shows that the X and Y coils are non-coplanar. Therefore, said coils are not overlapping literally in the general sense and in the definition set forth in Revie. Further, the Z coil is also not overlapping with either the X or Y coils because the orientation is not the same (Z is perpendicular to X and Y in coordinate systems) and also because the Z coil surrounds the two X coil portions and the 2 Y coil portions and does not share the same space. Since Sharma does not actually comply with the overlapping prohibition suggested in Revie, Sharma fails to render Revie unfit for its intended purpose when the two references are combined.
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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.
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/RAJEEV P SIRIPURAPU/Primary Examiner, Art Unit 3798