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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 April 13, 2026 has been entered.
Status of the Claims
This Office Action is responsive to the amendment filed February 13, 2026. As directed by the amendment: Claims 37, 42, and 43 have been amended. Claims 1-36, 38-41, and 46-51 have been cancelled. Claims 52-55 are newly added. Claims 37, 42-45, and 52-55 are presently pending in this application.
Claim Rejections - 35 USC § 112(a)
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 37, 42-45, and 52-55 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.
Regarding claim 37, ll. 18-21, the phrase “wherein said first and second intracorporeal tags are securely fixed at their respective fixation locations prior to said resection, and remain fixed throughout said resection without removal” render new matter as the originally filed disclosure is silent on this feature. Applicant is suggested to cancel any new matter in order to overcome this rejection.
Regarding claim 53, ll. 1-3, the phrase “wherein the displacement metric is determined exclusively from the tag system without anatomical landmark identification, bone surface registration, or establishment of an operating room coordinate system” renders new matter as the originally filed disclosure is silent on this feature. Applicant is suggested to cancel any new matter in order to overcome this rejection.
Claims 42-45, 52, 54, and 55 are rejected on being dependent to a rejected base claim.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 53 and 55 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 53, ll. 1-3, the phrase “wherein the displacement metric is determined exclusively from the tag system without anatomical landmark identification, bone surface registration, or establishment of an operating room coordinate system” is unclear as to how the tag system is without anatomical landmark identification, bone surface registration, or establishment of an operating room coordinate system. Amendment and clarification are required.
Regarding claim 55, ll. 2-3, the phrase “said second intracorporeal tag does not include a second set of microelectronics” is confusing because it appears the tag itself is considered a microelectronic. Amendment and clarification are required.
Examiner’s Note
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 37, 42-44, and 52-55 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hladio et al. (US 2014/0275940), herein referred to as Hladio, and in view of Roche (US 2010/0100011).
Regarding claim 37, Hladio discloses a system (200) for monitoring an anatomical displacement within a body (¶34 and figure 2), the system (200) comprising a tag system (figure 2) consisting essentially of a first tag (202+206+208) and a second tag (210+214+216), the first tag (202+206+208) securely configured to (i.e. capable of) be fixed to a pelvis (204) at a first fixation location (figure 2), the second tag (210+214+216) configured to (i.e. capable of) be securely fixed to a femur (212) at a second fixation location (figure 2), the femur (212) articulating with the pelvis (204) (¶1), wherein a relative positional relationship between the first and second tags (figure 2) is modified by a hip replacement procedure including a resection of the femur (¶40), wherein the first and second tags (figure 2) are configured to (i.e. capable of) wirelessly intercommunicate (¶37) to collectively and continuously determine a displacement metric responsive to the relative positional relationship during the procedure (e.g. pose, ¶37), the first tag (202+206+208) including a first set of microelectronics (¶37 and figure 2), and wherein the first and second tags (figure 2) are securely fixed at their respective fixation locations prior to the procedure resection (figure 2), and remain fixed throughout the resection (figure 2) without removal (capable of not being removed), and wherein the pelvis (204) and the femur (212) define a leg length (¶34) and a leg offset (¶34), and wherein the displacement metric (¶20, ¶21) directly represents a modification of at least of the leg length (¶34) and the leg offset (¶34).
Yet, Hladio lacks wherein the first and second tags are intracorporeal.
However, Roche teaches first and second tags (e.g. 806+904 or 202+204) are intracorporeal (figure 9).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute Hladio’s first tag and second tag with a first intracorporeal tag and a second intracorporeal tag as taught by Roche, since such a modification is a mere substitution of known sensors for another to yield predictable results.
Regarding claim 42, the modified Hladio’s system has wherein each intracorporeal of the tag system (the modified Hladio’s tag system) includes one or more devices selected from a group consisting of a passive sensor (¶34, ¶55 of Roche), an active sensor (¶34 of Roche), an active tag, an active reference, a hybrid sensor, a hybrid tag, a hybrid reference, and combinations thereof (¶34, ¶55 of Roche).
Regarding claim 43, the modified Hladio’s system has wherein each the intracorporeal tag (e.g. 806+904 or 202+204 of Roche) includes a bone-penetrating mechanical fixator having one or more structures (¶34 of Roche) selected from the group consisting of a fastener, a screw (¶34 of Roche), an anchor, a plug, a nail, a clip, and combinations thereof.
Regarding claim 44, the modified Hladio’s system has wherein a particular one tag (e.g. 806+904 or 202+204 of Roche) wirelessly transmits a status signal (¶42 of Roche) including the displacement metric (¶53 of Roche) and further comprising a tag interface (218 of Hladio) disposed outside the body and configured for (i.e. capable of) receipt of the status signal (¶42 of Roche).
Regarding claim 52, the modified Hladio’s system has wherein the fixation locations (figure 2 of Hladio) define a cartesian reference frame (x,y,z coordinate system) and the displacement metric is configured to (i.e. capable of) include an X-axis displacement (x,y,z coordinate system) and a Y-axis displacement (x,y,z coordinate system), wherein a first one of the axis displacements directly represents a change to the leg length (¶34 of Hladio) during the hip replacement procedure including the resection, and wherein a second one of the axis displacements directly represents a change to the leg offset (¶34 of Hladio) during the procedure.
Regarding claim 53, the modified Hladio’s system is capable of having wherein the displacement metric (¶34, ¶37 of Hladio) is determined exclusively from the tag system (the modified Hladio’s tag system) without anatomical landmark identification, bone surface registration, or establishment of an operating room coordinate system.
Regarding claim 54, the modified Hladio’s system has wherein the tag system (the modified Hladio’s tag system) includes an active tag system (¶34 of Roche) wherein the second intracorporeal tag includes a second set of microelectronics (¶34 of Roche), and wherein the active tag system continuously determines (e.g. real time, ¶34 of Hladio), during the hip replacement procedure including the resection, the displacement metric responsive to a set of data exchanged between the intracorporeal tags (e.g. 806+904 or 202+204 of Roche) establishing both a separation distance and an angle therebetween (e.g. leg length and leg offset).
Regarding claim 55, the modified Hladio’s system has wherein said tag system includes a hybrid tag system (¶34 of Roche) wherein the second intracorporeal tag does not include a second set of microelectronics, and wherein the hybrid tag system (¶34 of Roche) continuously determines (e.g. real time, ¶34 of Hladio), during the hip replacement procedure including the resection, the displacement metric responsive to a set of data developed by the first intracorporeal tag establishing, with respect to the intracorporeal tags (e.g. 806+904 or 202+204 of Roche), both a separation distance and an angle therebetween (e.g. leg length and leg offset).
Claim(s) 45 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hladio and Roche as applied to claims above, and further in view of van der Weide et al. (US 2017/0095313), herein referred to as van der Weide.
Regarding claim 45, the modified Hladio’s system discloses all the features/elements as claimed but lacks wherein the body is disposed on a table and wherein the tag interface is disposed in a pad positioned between the body and the table.
However, van der Weide teaches a body (figure 7) disposed on a table (190 and figure 7), wherein a control unit (60) (interface) (186 and figure 8) is disposed in a pad (50) (185 and figure 8) positioned between the body (figure 7) and the table (figure 7).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide Hladio's system with a body is disposed on a table, wherein the interface is disposed in a pad positioned between the body and the table as taught by van der Weide, since such a modification would provide an alternative location for the control unit.
Response to Arguments
Applicant's arguments filed February 13, 2026 have been fully considered but they are not persuasive.
Applicant’s arguments on pages 5-8, under 35 U.S.C. 102(a)(1), of the Remarks are directed to the amended claims and the reference Hladio. Applicant argues that the reference Hladio does not teach an intracorporeal system. Thus, the Examiner has relied on the reference Roche to teach applicant’s amended features (e.g. a first intracorporeal tag and a second intracorporeal tag), see Office Action above.
Conclusion
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/SI MING KU/Primary Examiner, Art Unit 3775
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