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
Claims 31-32 and 60-61 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 28 September 2025.
Claim Rejections - 35 USC § 101
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 10, 14 and 21 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). Claim 10 requires “a joint sensor measures a gait cycle”; claim 14 requires “a joint sensor measures a walking session”; claim 21 requires “the bioimpedance sensor delivers a first current” and “the bioimpedance sensor delivers a second current”. These limitations claim the human body as part of the inventive system. The Examiner suggests amending the claims to include “configured for” (“adapted to”, etc.) language to preclude this interpretation.
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.
Claims 1-2, 8, 17, 26 and 29-30 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
Claims 1, 8 and 29-30 are directed to a system (machine) for assessing joint health.
Step 2A, Prong One
Regarding claim 1, the recited steps are directed to a mental process of performing concepts in a human mind or by a human using a pen and paper. See MPEP § 2106.04(a)(2)(Ill). The limitation(s) of “provide an assessment of joint health through interpretation of measurements from the joint sensor and the bioimpedance sensor” is/are a process that, as drafted, covers performance of the limitation by a human mind (including an observation, evaluation, judgment, opinion) under the broadest reasonable standard interpretation. For example, these limitations are nothing more than glancing at numbers on a chart or display and assessing a patient using the information presented.
Step 2A, Prong Two
The judicial exception is not integrated into a practical application. In particular, claim 1 also recites “a joint sensor configured to measure at least one non-acoustic characteristic of a joint; a bioimpedance sensor configured to measure bioimpedance of the joint exposed to electrical current at a plurality of frequencies; a processor; and a memory”. The joint sensor and bioimpedance sensor amount to nothing more than the pre-solution activity of data gathering. The processor and memory are recited at a high-level of generality and amount to nothing more than parts of a generic computer. Merely including instructions to implement an abstract idea on a computer does not integrate a judicial exception into practical application.
Step 2B
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of amount to nothing more than mere pre-solution activity of data gathering, which does not amount to an inventive concept. The additional elements recited above are well known in the field of data measurement. Moreover, simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry, is discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984. See MPEP § 2106.05(d). In this case, elements of general computer are being used to implement the abstract idea of assessing joint health, and as per the Review article (“Fundamentals, Recent Advances, and Future Challenges in Bioimpedance Devices for Healthcare Applications”, first paragraph of Introduction and third full paragraph of p. 2), it is well known in the field of healthcare to use bioimpedance sensors to assess joint health.
Regarding dependent claims 2, 8, 17, 26 and 29-30, the limitations of claim 1 further defines the limitations already indicated as being directed to the abstract idea. See the above reference for features that are well-known in the art.
Claim Rejections - 35 USC § 102
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.
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.
Claims 1-2, 8, 17-19, 21 and 26-29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Inan et al (U.S. 2018/0160966). Inan discloses (Figure 2) a joint sensor (par. 0041-0042) configured to measure at least one non-acoustic characteristic of a joint; a bioimpedance sensor configured (Abstract; par. 0033, 0118 and 0199-0200) to measure bioimpedance of the joint exposed to electrical current at a plurality of frequencies; a processor (par. 0054-0062); and a memory (par. 0058 and 0195-0196), the memory comprising instructions that, when executed by the processor, cause the processor to provide an assessment of joint health through interpretation of measurements from the joint sensor and the bioimpedance sensor (“a health assessor comprising at least one processor that provides an assessment of joint health through processing the signals from the first and the second sensing assemblies, and an output assembly capable of providing an indication of the joint health from the health assessor to a user of the system.”).
Regarding claim 2, Inan discloses (par. 0223 and 0257) at least the assessment of joint health can differentiate between a healthy joint and an injured joint (“The peak-to-peak amplitudes of these waveforms, Δrpp and Δxpp, are extracted as they might show differences in injured and healthy knees.”).
Regarding claim 8, Inan discloses (par. 0264) at least provide the assessment of joint health based at least in part on the ratio of the chances in bioimpedance (“customized physiology-driven algorithms for detecting features from the measured signals, and human subjects experiments to both evaluate the capabilities in detecting small changes in local bioimpedance due to edema and modified blood flow.”).
Regarding claim 17, Inan discloses (par. 0128) the joint sensor is a kinematic sensor configured for sensing characteristics related to joint movement.
Regarding claim 18, Inan discloses (par. 0038, 0122 and 0168) the joint sensor comprises one or more inertial measurement units.
Regarding claim 19, Inan discloses (par. 0041-0042) the joint sensor is configured to measure at least angular velocity at the joint; and wherein the bioimpedance sensor is configured to sense characteristics related to bioimpedance of the joint when the angular velocity equals zero during movement.
Regarding claim 21, Inan discloses (par. 0118, 0201-0203 and 0227) the plurality of frequencies comprises a first frequency and a second frequency; and at least the first frequency is 1-50 kHz (“A bandwidth of 15 Hz-21 kHz was chosen, as knee joint sounds can range between these frequencies.”).
Regarding claim 26, Inan discloses (Figure 2; par. 0045-0046 and 0054) the joint sensor comprises a first wearable sensor for placement proximate the joint; and wherein the bioimpedance sensor comprises a second wearable sensor for placement proximate the joint.
Regarding claim 27, Inan discloses (par. 0037 and 0040) an output capable of providing an indication of joint health to a user of the system (“The present invention informs the user and/or caregiver of the status of the joint health that the processor outputs.”).
Regarding claim 28, Inan discloses (par. 0122 and 0190) a wireless communicator (“An algorithm requiring a one-time training similar to this can be implemented on a smart phone that wirelessly communicates with the bioimpedance hardware.”).
Regarding claim 29, Inan discloses (Figure 6) the joint is an ankle joint (E4).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEBORAH L MALAMUD whose telephone number is (571)272-2106. The examiner can normally be reached Mon - Fri 1:00-9:30 Eastern.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Unsu Jung can be reached at (571) 272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DEBORAH L MALAMUD/Primary Examiner, Art Unit 3792