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 .
Status of the Claims
This Office Action is responsive to the amendment filed August 12, 2025. As directed by the amendment: Claims 1-36 have been cancelled. Claims 37-51 are newly added and 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 37-51 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. 13-15, the phrase “wherein said first and second tags are immutably fixed at their respective fixation locations prior to said procedure, throughout said procedure, and after said procedure” renders new matter as the originally filed disclosure is silent on wherein said tags are immutably fixed at their respective fixation locations prior to said procedure and after said procedure. Applicant is suggested to cancel any new matter to overcome this rejection.
Regarding claim 51, ll. 9-10, the phrase “wherein all N of said tags are pre-resectionally and immutably fixed prior to said procedure” renders new matter as the originally filed disclosure is silent on this feature. Applicant is suggested to cancel any new matter to overcome this rejection.
Claims 38-50 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.
Claims 37-51 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 37, ll. 13, the phrase “wherein said first and second tags are immutably fixed at their respective fixation locations prior to said procedure, throughout said procedure, and after said procedure” is unclear as to how these tags are immutably fixed. Amendment and clarification are required.
Regarding claim 51, ll. 9-10, the phrase “wherein all N of said tags are pre-resectionally and immutably fixed prior to said procedure” is unclear as to how the tags are immutably fixed. Amendment and clarification are required.
Claims 38-50 are rejected on being dependent to a rejected base claim.
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 § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 37-44 and 46-51 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hladio et al. (US 2014/0275940), herein referred to as Hladio.
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) fixed to a first anatomical structure (204) within the body at a first fixation location (figure 2), the second tag (210+214+216) fixed to a second anatomical structure (212) within the body at a second fixation location (figure 2), wherein a relative positional relationship between the first and second fixation locations (figures 1 and 5) is modified by a procedure (e.g. THA, ¶40), wherein the first and second tags (figure 2) are configured for (i.e. capable of) a wireless intercommunication (¶37) to collectively and autonomously determine a displacement metric responsive to the relative positional relationship during the procedure (e.g. pose, ¶37), and wherein the first and second tags (202+206+208 and 210+214+216) are immutably fixed at their respective fixation locations (figure 2) prior to the procedure, throughout the procedure, and after the procedure (figure 2).
Regarding claim 38, Hladio discloses wherein the procedure includes a resection of at least one of the anatomical structures (e.g. THA, ¶40) and wherein the displacement metric is determined exclusively from a pre-resection fixation of the tags (¶42 and figure 3).
Regarding claim 39, Hladio discloses wherein the procedure includes a hip replacement (e.g. THA, ¶40), wherein the first anatomical structure includes a pelvis (204), and wherein the second anatomical structure includes a femur (212) articulating with the pelvis (204) (figures 4 and 5).
Regarding claim 40, Hladio discloses wherein the anatomical structures define a leg length (¶34) and a leg offset (¶34), wherein the procedure (¶40) produces a modification to one or more of the leg length (¶40) and the leg offset (¶40), and wherein the displacement metric is directly related to the modification (¶40).
Regarding claim 41, Hladio discloses wherein the displacement metric includes one or more of a delta leg length (figure 6) and a delta leg offset (figure 6) wherein the delta leg length and the delta leg offset are responsive to the modification (figure 6).
Regarding claim 42, Hladio discloses wherein a tag of the tag system includes one or more devices selected from a group consisting of a passive sensor, an active sensor, a passive tag, an active tag, a passive reference, an active reference, a hybrid sensor, a hybrid tag, a hybrid reference, and combinations thereof (¶38).
Regarding claim 43, Hladio discloses wherein each the tag includes a bone-penetrating mechanical fixator (208, 216) having one or more structures selected from the group consisting of a fastener, a screw, an anchor (figure 2), a plug, a nail, a clip, and combinations thereof.
Regarding claim 44, Hladio discloses wherein a particular one tag (202) wirelessly transmits a status signal (¶37) including the displacement metric (¶34, ¶37) and further comprising a tag interface (218) disposed outside the body (figure 2) and configured for (i.e. capable of) receipt of the status signal (¶37).
Regarding claim 46, Hladio discloses wherein the body includes a pelvic cartesian reference frame (x,y,z coordinate system) (figure 2) and wherein the tag system includes a tag cartesian reference frame (another x,y,z coordinate system) (figure 2) defined with respect to the pelvic cartesian reference frame (x,y,z coordinate system).
Regarding claim 47, Hladio discloses wherein the pelvic cartesian reference frame includes an X-axis and a Y-axis (x,y,z coordinate system), wherein the displacement metric includes an X-axis displacement component and a Y-axis displacement component (x,y,z coordinate system), wherein the X-axis displacement component is directly related to a delta leg offset (¶34) and wherein the Y-axis displacement component is directly related to a delta leg length (¶34).
Regarding claim 48, Hladio discloses further comprising a pelvic plane (figure 2) defined by the X-axis and the Y-axis (figure 2), wherein the tags (202+206+208 and 210+214+216) are within the pelvic plane (figure 2).
Regarding claim 49, Hladio discloses wherein the fixation locations of the tags (figure 2) are in line parallel to the X-axis (figure 2) and the displacement metric includes only X-axis displacement components (figure 2).
Regarding claim 50, Hladio discloses wherein the fixation locations of the tags (figure 2) are in line parallel to the Y-axis (figure 2) and the displacement metric includes only Y-axis displacement components (figure 2).
Regarding claim 51, Hladio discloses a system (200) for a body (figure 2), the system establishing a status within the body (¶34), comprising a tag system (figure 2) including an N number of tags (202+206+208 and 210+214+216), N greater than or equal to 2 (figure 2), the tags of the tag system (202+206+208 and 210+214+216) configured for (i.e. capable of) immutable fixation to one or more anatomical structures within the body at N different fixation locations (figure 2), wherein a first fixation location (¶34) undergoes a relative displacement with respect to a second fixation location (¶34) responsive to a procedure (e.g. THA, ¶40) that includes a resection producing the relative displacement (¶40), wherein all N of the tags (202+206+208 and 210+214+216) are pre-resectionally and immutably fixed prior to the procedure (figure 2), and wherein the N number of tags (202+206+208 and 210+214+216) are configured to (i.e. capable of) communicate among one another (¶37) to collectively determine during the procedure a displacement metric responsive to the relative displacement (¶37, ¶38).
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) 45 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hladio (US 2014/0275940) in view of van der Weide et al. (US 2017/0095313), herein referred to as van der Weide.
Regarding claim 45, 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 (¶90 and figure 7), wherein a control unit (60) (interface) (¶86 and figure 8) is disposed in a pad (50) (¶85 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 August 12, 2025 have been fully considered but they are not persuasive.
Applicant’s arguments on pages 5-6, under 35 U.S.C. 102(a)(1) with respect to the reference Roche has been considered but are moot because the new ground of rejection does not rely on this reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
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/SI MING KU/Primary Examiner, Art Unit 3775
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