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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11 December 2025 has been entered.
Claim Rejections - 35 USC § 112
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 41 and 42 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.
Claim 41 recites the limitation "the orientation" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 41 recites the limitation "the first bone" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 41 recites the limitation "the second bone" in line 2. There is insufficient antecedent basis for this limitation in the claim.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 21, 23, 24 and 27-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stein et al., U.S. PG-Pub 2011/0319755 in view of Bhandari, U.S. PG-Pub 2011/0275957 (previously cited in PTO-892 dated 05/23/2025).
Regarding claim 21, Stein et al. discloses a method of kinetic assessment of a joint of a musculoskeletal system, comprising: adjusting the joint to a predetermined flexion angle; measuring a position of a first bone (102) of the joint relative to a second bone (108) of the joint; capturing a reference position of the joint corresponding to a feature of the first bone; displaying an orientation of the first bone relative to the second bone on a graphical user interface (GUI) (via 110); and repositioning the joint to a new flexion angle based on the reference position of the joint and the displayed orientation of the first bone relative to the second bone (Figs. 1-2 and paragraphs [0048], [0053], [0059], [0060], [0064]).
Stein et al. does not disclose wherein the feature of the first bone is a landmark on the first bone and displaying the landmark of the first bone on the graphical user interface (GUI).
Bhandari discloses a method of kinetic assessment of a joint that includes capturing a reference position of a joint (knee) corresponding to a feature of a first bone, wherein the feature of the first bone is a landmark on the first bone and displaying the landmark of the first bone in order to create a model that tracks the position and orientation of a femur and tibia in real time, with the model being used to quantify the extent of deformity through movement of the bones such that the surgeon uses that information to make initial soft-tissue releases around the joint (paragraph [0126] and Fig. 11).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the feature of the first bone of Stein et al. to be a landmark of the first bone and displaying the landmark of the first bone on the graphical user interface (GUI) in view of Bhandari to permit tracking of the joint in real time by a surgeon to quantify the extent of any deformity through movement of the first and second bones and use that information to make initial soft-tissue releases around the joint.
Regarding claim 23, Stein et al. discloses the invention essentially as claimed except for displaying on the GUI an indicator dial configured to indicate an orientation of the knee joint based on the sensor data.
Bhandari discloses a method of kinetic assessment of a joint where an indicator dial is displayed on a GUI to indicate an orientation of a joint based on sensor data (from 70) (Fig. 9) in order to determine the center of the joint and such that anatomical landmarks around the joint are mapped to provide more data for the joint center calculation (paragraph [0124]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Stein et al. to include displaying on the GUI an indicator dial configured to indicate an orientation of the knee joint based on the sensor data in view of Bhandari to permit determining the center of the knee joint and mapping landmarks around the knee joint to provide more data for knee joint center calculation.
Regarding claim 24, Stein et al. further comprises displaying an angle between the first bone and the second bone (Figs. 1-2 and paragraphs [0048], [0059]).
Regarding claims 27-29, Stein et al. discloses wherein the GUI (via 110) further displays data indicative of a mechanical axis and the predetermined flexion angle (paragraphs [0053], [0059],[0060], [0064]); further comprising updating the GUI in real-time to display the orientation of the first bone (102) relative to the second bone (108) as the joint is repositioned; and further comprises displaying a metric in degrees (angles are measured in degrees) of the orientation of the first bone relative to the second bone, the displayed metric being updated in real time (paragraphs [0048], [0054], [0059]).
Regarding claim 30, Stein et al. further comprises couples a measurement device (100) to the joint, wherein the GUI (via 110) displays an orientation of the first bone (102) and the second bone (108) of the joint based on data received from the measurement device, wherein the measurement device comprises a sensor configured to detect orientation of the first bone and the second bone of the joint (Fig. 1 and paragraph [0048]).
Claim(s) 21 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over McIntosh et al., U.S. PG-Pub 2011/0160738 in view of Bhandari, U.S. PG-Pub 2011/0275957 (previously cited in PTO-892 dated 05/23/2025).
Regarding claims 21 and 22, McIntosh et al. discloses a method of kinetic assessment of a joint of a musculoskeletal system, comprising: adjusting the joint to a predetermined flexion angle; measuring a position of a first bone (femur) of the joint relative to a second bone (tibia) of the joint; capturing a reference position of the joint corresponding to a feature of the first bone displaying an orientation of the first bone relative to the second bone on a graphical user interface (GUI) (via 104); and repositioning the joint to a new flexion angle based on the displayed orientation of the first bone relative to the second bone (Fig. 1A and paragraphs [0035] and [0075]); and displaying on the GUI a value representative of a slope of the joint (paragraph [0082]).
McIntosh et al. does not disclose wherein the feature of the first bone is a landmark on the first bone and displaying the landmark of the first bone on the graphical user interface (GUI).
Bhandari discloses a method of kinetic assessment of a joint that includes capturing a reference position of a joint (knee) corresponding to a feature of a first bone, wherein the feature of the first bone is a landmark on the first bone and displaying the landmark of the first bone in order to create a model that tracks the position and orientation of a femur and tibia in real time, with the model being used to quantify the extent of deformity through movement of the bones such that the surgeon uses that information to make initial soft-tissue releases around the joint (paragraph [0126] and Fig. 11).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the feature of the first bone of McIntosh et al. to be a landmark of the first bone and displaying the landmark of the first bone on the graphical user interface (GUI) in view of Bhandari to permit tracking of the joint in real time by a surgeon to quantify the extent of any deformity through movement of the first and second bones and use that information to make initial soft-tissue releases around the joint.
Claim(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stein et al., U.S. PG-Pub 2011/0319755 in view of Bhandari, U.S. PG-Pub 2011/0275957 as applied above and further in view of Leitner et al., U.S. PG-Pub 2004/0105086.
Regarding claim 25, Stein et al. discloses the invention essentially as claimed except for wherein the GUI provides a color-coded feedback when the joint is within a predetermined fixation angle range of at least of at least one of the predetermined flexion angle and the new flexion angle.
Leitner et al. discloses a display changes color when a certain parameter is within a certain range (paragraph [0025]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Stein et al. such that the GUI provides a color-coded feedback when the joint is within a predetermined fixation angle range of at least of at least one of the predetermined flexion angle and the new flexion angle further in view of Leitner et al. to permit a user/surgeon be given a quick visual cue when reaching a predetermined parameter.
Allowable Subject Matter
Claims 31-33 and 35-40 are allowed.
Claims 41 and 42 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant’s arguments, see Remarks, filed 11 December 2025, with respect to the rejection(s) of claim(s) 21 under 35 U.S.C. 102(a)(1) and 102(a)(2) to Stein et a., U.S. PG-Pub 2011/0319755 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Bhandari, U.S. PG-Pub 2011/0275957.
Furthermore, applicant contends that Bhandari does not does not cure the deficiencies in Stein et al. with respect to claim 21. However, as can be seen in the rejection of claim 21 to Stein et al. in view of Bhandari above, Bhandari does disclose capturing a landmark of a first bone and displaying the landmark of the first bone.
Applicant’s arguments, see Remarks, filed 11 December 2025, with respect to the rejection(s) of claim(s) 21 under 35 U.S.C. 102(a)(2) to McIntosh et al., U.S. PG-Pub 2011/0160738 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Bhandari, U.S. PG-Pub 2011/0275957.
Furthermore, applicant contends that Bhandari does not does not cure the deficiencies in McIntosh et al. with respect to claim 21. However, as can be seen in the rejection of claim 21 to McIntosh et al. in view of Bhandari above, Bhandari does disclose capturing a landmark of a first bone and displaying the landmark of the first bone.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eric Gibson whose telephone number is (571)270-5274. The examiner can normally be reached Monday-Thursday ~6:00 A.M. to 4:00 P.M. (CST).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Kevin Truong, at (571) 272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERIC S GIBSON/ Primary Examiner, Art Unit 3775