DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 December 19, 2025 has been entered.
Claim Objections
Claim 14 is objected to because of the following informalities: in line 17, “at least one an” should be - - at least one - - to correct a minor typographical error. Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 21-34 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
In claim 21, the recitation “..a first device of the navigation system is coupled to the first hole in the bone..” and the recitation “..a second device of the navigation system is coupled to the second hole in the second bone…” positively recites a part of a human. It is suggested that Applicant amend the claim to recite “..a first device of the navigation system is configured to be coupled to the first hole in the first bone..” and “..a second device of the navigation system is configured to be coupled to the second hole in the second bone..”
In claim 29, the recitation “..a first device of the navigation system is coupled to the first hole in the bone..” and the recitation “..a second device of the navigation system is coupled to the second hole in the second bone…” positively recites a part of a human. It is suggested that Applicant amend the claim to recite “..a first device of the navigation system is configured to be coupled to the first hole in the first bone..” and “..a second device of the navigation system is configured to be coupled to the second hole in the second bone..”
Appropriate correction is required.
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 21-34 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.
In claim 21, the recitation “..a first implantable device comprising an inertial measurement unit (IMU) configured to be inserted in the first hole in the first bone” and the recitation “..a second implantable device comprising an inertial measurement unit (IMU) configured to be inserted in the second hole in the second bone” renders the claim vague and indefinite. It is unclear whether a portion of the first implantable device is inserted in the first hole in the first bone or the IMU is inserted in the first hole of the first bone. Similarly, it is unclear whether a portion of the second implantable device is inserted in the second hole in the second bone or the IMU is inserted in the second hole of the second bone.
In claim 21, the recitation “..a first implantable device comprising an inertial measurement unit (IMU) configured to be inserted in the first hole in the first bone” and the recitation “..a second implantable device comprising an inertial measurement unit (IMU) configured to be inserted in the second hole in the second bone” renders the claim vague and indefinite. It is unclear whether a portion of the first implantable device is inserted in the first hole in the first bone or the IMU is inserted in the first hole of the first bone. Similarly, it is unclear whether a portion of the second implantable device is inserted in the second hole in the second bone or the IMU is inserted in the second hole of the second bone.
In claim 28, “wherein displaying the position of the knee joint…” lacks antecedent basis.
In claim 29, the recitation “..a first implantable device comprising first sensor configured to be inserted in the first hole in the first bone” and the recitation “..a second implantable device comprising a second sensor configured to be inserted in the second hole in the second bone” renders the claim vague and indefinite. It is unclear whether a portion of the first implantable device is inserted in the first hole in the first bone or the first sensor is inserted in the first hole of the first bone. Similarly, it is unclear whether a portion of the second implantable device is inserted in the second hole in the second bone or the second sensor is inserted in the second hole in the second bone.
In claim 29, the recitation “wherein the first device and the second are configured..” renders the claim vague and indefinite because “the second” is incomplete. It appears Applicant intended to recite “a second device.”
In claim 32, “the first prosthetic component” lacks antecedent basis.
In claim 33, the recitation “…wherein the first implantable device comprises an optical device” renders the claim vague and indefinite because it is unclear whether this is the first sensor of the first implantable device or another device. Applicant’s disclosure describes “the position measurement system to an also be a GPS chip, an acoustical ranging device, optical devices, inertial devices, magnetometers, inclinometers, or MEMs devices.” Applicant’s disclosure broadly recites “optical devices” but does not describe it with sufficient detail to understand the scope of Applicant’s claimed invention.
Regarding claim 34, the recitation “…wherein the first implantable device comprises an acoustical ranging device” renders the claim vague and indefinite because it is unclear whether this is the first sensor or a second sensor in the first implantable device or the second sensor of the second implantable device. Applicant’s disclosure describes “the position measurement system to an also be a GPS chip, an acoustical ranging device, optical devices, inertial devices, magnetometers, inclinometers, or MEMs devices.” Applicant’s disclosure broadly recites “acoustical ranging device” but does not describe it in sufficient detail to understand the scope of Applicant’s claimed invention.
Appropriate correction is required.
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) 21-28 are rejected under 35 U.S.C. 103 as being unpatentable over Roche (US 2010/0100011 A1).
Regarding claims 21-23, 26 and 27, Roche discloses a surgical system including: a first prosthetic component (Fig. 8); a second prosthetic component (604, Fig. 6); a third prosthetic component 606 operably coupled to both the first prosthetic component 608 and the second prosthetic component 604 (Fig. 6); a navigation system (Fig. 5) wherein a first device 202 is configured to be coupled to a first bone 102; and a second device 204 is configured to be coupled to a second bone 104 (para 0040]) wherein the first device 202 and the second device 204 are configured to measure position and/or orientation of the first bone 102 relative to the second bone 104 (paras [0034]-[0040]).
Regarding claim 21, Roche discloses a position sensor (i.e. the first device 202 or the second device 204) to include a mems accelerometer or inertial sensor or inertial measurement unit.
Regarding claim 28, Roche discloses displaying the relational positioning in real time (Fig. 2, para [0034] and para [0040]).
Regarding claims 21 and 24, Roche does not explicitly disclose the use of additional implantable devices or sensors in the tibia and femur. In another embodiment (Fig. 9), Roche discloses one or more sensor arrays coupled to a first bone (pelvis) and one or more sensor arrays are placed on a second bone of a joint (femur) wherein the one or more sensor arrays provide position and measurement data (Fig. 9 and para [0058]).
It would have been obvious to one of ordinary skill in the art to have provided an additional sensor array 202 or first implantable device 202 and an additional sensor array 204 or second implantable device 204 wherein the sensors are permanently incorporated into the bones for post-operative monitoring of functioning of the device.
Claim(s) 29-34 are rejected under 35 U.S.C. 103 as being unpatentable over in view of Morgan et al. (11191594) in view of Roche (US 8372153).
Regarding claims 29-34, Morgan et al. disclose a navigation system configured to be coupled to a first bone of a knee joint and a second bone of the knee joint wherein a first tracker or first device (44 or 46, Fig. 3) is configured to be coupled to a first hole in the first bone by means of a tracker support in the form of a screw; a second tracker or second device (118, Figs. 4A and 4B) is configured to be coupled to a second hole in a second bone by means of a bone pin wherein the first and second trackers are configured to measure position and/or orientation of the objects being tracked (herein the first bone relative to the second bone) (col. 4, lines 17-67, cols. 5-13 and col. 14, lines 1-55).
Regarding claims 30 and 31, Morgan et al. disclose a navigation computer 26 that is configured to receive signals from the tracking devices (col. 8, lines 16-67 and col. 9, lines 1-14).
Morgan et al. disclose all elements of the claimed invention except for: (1) a first implantable device including a first sensor that is configured to be inserted in a first hole in the first bone; and (2) a second implantable device including a second sensor configured to be inserted in a second hole in the second bone; wherein the first and second sensors enable measurement of at least one of movement, position or orientation of the first bone and the second bone post-operatively.
Roche discloses first and second implantable devices or sensors that are capable of measuring relative position of the implant and abnormal motion (relative position of bones) post operatively to evaluate changes over time (Figs. 6, 12 and 13, col. 8, lines 15-67, cols. 9-13 and col. 14, lines 1-31).
Regarding claim 32, Roche discloses providing a first prosthetic component (femoral implant, Figs. 12 and 13) and a second prosthetic component (tibial implant, Figs. 12 and 13).
Regarding claim 33, Roche discloses the use of an optical device or sensor (col. 2, lines 28-32).
Regarding claim 34, Roche discloses ultrasound sensors (interpreted to mean “acoustical ranging device”).
It would have been obvious to one of ordinary skill in the art to have incorporated additional implantable sensors, as taught by Roche, when performing knee arthroplasty to evaluate changes over time post operatively for better surgical outcomes.
Response to Arguments
Applicant's arguments have been fully considered by the Examiner. New grounds of rejection have been made in this office action.
Allowable Subject Matter
Non application of prior art to claims 14-20 indicates allowable subject matter provided the claim objection is overcome.
Conclusion
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January 29, 2026
/Anu Ramana/Primary Examiner, Art Unit 3775