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 .
Election/Restrictions
Applicant’s election of Group I (claims 1-17), Surgical Method Species II (Knee Joint Surgery) and Implant Species b (Dual Implant) is in the reply filed on May 18, 2026 acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claims 1-17 and 21-23 have been examined on the merits in this office action. Claims 18-20 have been withdrawn from further consideration because they are directed to a non-elected invention.
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 17 and 21-23 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 17, the recitation “..configured to measure a parameter indicative of infection” renders the claim vague and indefinite because Applicant’s specification does not describe which of several parameters is indicative of infection.
In claim 21, the preamble recites “a method for optimizing a medical treatment plan…”,” however, the body of the claim does not recite inserting one implant or two implants enable optimizing a medical treatment plan. It is suggested that a conclusory step for optimizing the medical treatment plan be provided.
In claim 21, the recitation “a parameter indicative of infection” renders the claim vague and indefinite because Applicant’s disclosure, does not describe which of several parameters is indicative of infection.
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) 1-3, 9-17 and 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Daley et al. (US 11158415) in view of Roche (US 20210212566 A1).
Daley et al. disclose a method for optimizing a medical treatment plan, the
method including the steps of: receiving preoperative information for an instant patient or intraoperative information for the instant patient (col. 2, lines 64-67, col. 3, lines 1-43 and col. 7, lines 5-44); determining, based on the received preoperative information or intraoperative information, an initial medical treatment plan for the instant patient (“generate preoperative or intraoperative plans based on feedback loops” (col. 3, lines 44-57)); and determining, based on the initial medical treatment plan, a position for
implantation of a first implant (col. 3, lines 1-43, col. 13, lines 48-67, col. 14 and col. 15, lines col. 4, lines 50-67, col. 5, lines 36-67 and col. 23, lines 10-22); wherein the stored information includes: (i) the preoperative information for the instant patient, and (ii) preoperative information, intraoperative information, and/or postoperative information from a plurality of previous patients having at least one characteristic in common with the instant patient (col. 5, lines 6-67).
Daley et al. disclose obtaining preoperative, intraoperative, and/or postoperative patient surgical data (col. 5, lines 6-67, col. 19, lines 9-58, col. 20, lines 64-67, col. 21, lines 1-10 and col. 23, lines 10-22).
Regarding claim 9, Daley et al. disclose creating patient specific implants and prosthesis which the surgeon uses during the surgical procedure (col. 10, lines 15-59).
Regarding claims 10 and 14, Daley et al. disclose changing the type of surgery in the operative plan (first input) based on data acquired during the surgical operation, such as partial knee replacement to total knee replacement plan (second input based on data acquired during the surgical operation (col. 3, lines 58-67, col. 4, lines 1-30, and col. 22, lines 6-12).
Regarding claims 15 and 16, Daley et al. disclose the use of haptically controlled features, such as selecting icons on a display (GUI) (col. 20, lines 48-63).
Daley et al. disclose all elements of the claimed invention except for: (1) a first implant that is configured to postoperatively gather kinematics data of the patient; (2) a second implant that is configured to postoperatively gather kinematics data of the patient; and (3) comparing first data from the first implant to second data from the second implant to determine postoperative kinematics data.
Roche discloses first and second implants with sensors to receive postoperative kinematics data wherein the sensor may be an accelerometer (inertial measure unit (IMU)) in each of a first implant and a second implant to provide position and movement data wherein the implant position is monitored by comparison of movement between the first and second implants (Figs. 16 and 39, paras [0147], [0189], [0191], [0272]-[0275], [0277] and [0286]).
Regarding claim 17, Roche discloses providing sensors that detect heat or acid to provide an early infection warning, heat or acid considered to be parameters indicative of infection (para [0164]).
It would have been obvious to one of ordinary skill in the art to have provided sensors in each of a first implant and a second implant as taught by Roche when performing surgery on a knee joint, according to the method of Daley et al., to provide movement and position data and early warning of an infection.
Regarding claim 21, it is assumed that only one implant is required and the implants in the method of the combination of Daley et al. and Roche are configured to or capable of being powered by a rechargeable battery. Claims 22 and 23 do not limit claim 1 when only one implant is required.
Claim(s) 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Daley et al. (US 11158415) and Roche (US 20210212566 A1), as applied to claim 1, in view of Bailey et al. (US 12440153).
For features of claim 1, see previous discussion for Daley et al. and Roche.
Regarding claim 5, Roche discloses the use of a battery to power sensors in the femoral and tibial implants (paras [0147] and [0201]).
The combination of Daley et al. and Roche disclose all elements of the claimed invention except for the use of a single use (non-rechargeable) battery in a first implant and a rechargeable battery in the second implant to power sensors in each respective implant.
Bailey discloses the use of non-rechargeable and rechargeable batteries depending on whether it is impractical to recharge the battery depending on the ability of the power source to provide power over a sufficient period of time (col. 3, lines 66-67, col. 4 and col. 5, lines 10-20).
Therefore, it would have been obvious to one of ordinary skill in the art to have provided the first and second implants in the method of the combination of Daley et al. and Roche with non-rechargeable (single use) and rechargeable batteries, as taught by Bailey, depending on the sensitivity of the sensors.
Claim(s) 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Daley et al. (US 11158415) and Roche (US 20210212566 A1), as applied to claim 1, in view of Motesharei et al. (US 20230410993 A1).
The combination of Daley et al. and Roche disclose all elements of the claimed invention except for: updating the postoperative exercise plan; updating the pain medication plan; and updating the discharge optimization plan.
Motesharei et al. disclose optimizing the initial exercise or rehabilitation plan, updating the pain medication plan and updating the discharge and/or length of stay optimization plan wherein the procedure plan including the rehabilitation plan, discharge and/or length of stay plan and pain medication plan is updated and/or modified based on intraoperative data for improvement of a surgical outcome (paras [0012], [0014], [0051], [0095] and [0156]).
It would have been obvious to one of ordinary skill in the art to have incorporated data related to rehabilitation (physical therapy or postoperative exercise), pain medication and discharge or length of stay, suggested by Motesharei et al. in the method of the combination of Daley et al. and Roche., to improve the outcome of the type of surgery performed on a patient.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anu Ramana whose telephone number is (571)272-4718. The examiner can normally be reached 8:00 am-5:00 pm.
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July 28, 2026
/Anu Ramana/Primary Examiner, Art Unit 3775
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