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 .
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.
Notice of Amendment
In response to the amendment(s) filed on 8/6/25, amended claim(s) 1, 3, 5, 11, 19, and 22, and canceled claim(s) 20 is/are acknowledged. The following new and/or reiterated ground(s) of rejection is/are set forth:
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-4, 6-9, 11-13, 15-18, and 21-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2005/0107726 to Oyen et al. (hereinafter “Oyen”) in view of U.S. Patent Application Publication No. 2018/0020973 to Hurley et al. (hereinafter “Hurley”).
For claim 1, Oyen discloses a method (para [0011]) for evaluating sensor data (para [0023]) of at least one orthopedic device (102) (Fig. 1) (para [0028]), the orthopedic device comprising sensors (166) (Fig. 3) (para [0036]) for acquiring the sensor data comprising properties, states, or changes of properties or states of the orthopedic device or of a user of the orthopedic device (para [0036]), wherein the sensors are connected to a transmitter (312) (Fig. 7) (para [0050]) either directly or via a storage unit (338) (Fig. 7) (para [0056]), the method comprising:
acquiring the sensor data using the sensors (para [0036]);
transmitting, with the transmitter, the sensor data to an evaluation unit (360) (Fig. 7) (para [0054]) in a computer network (306) (Fig. 7) (para [0050]);
processing the transmitted sensor data using the evaluation unit (para [0024]).
Oyen does not expressly disclose performing a risk analysis based on the evaluated sensor data; and displaying a recommendation to the user, a payer, an orthopedic technician, and/or a producer of the orthopedic device based on results of the risk analysis, wherein the recommendation is directed to usage of the orthopedic device, wherein performing the risk analysis is characterized in that the evaluation unit correlates data about the orthopedic device and/or comparable orthopedic devices and derives therefrom probabilities about malfunctions or disadvantageous effects and transmits these probabilities to the user, the orthopedic technician, the payer, and/or the producer.
However, Hurley teaches performing a risk analysis based on the evaluated sensor data (392) (Fig. 12B) (para [0143] and [0156]-[0159]); and displaying a recommendation to the user, a payer, an orthopedic technician, and/or a producer of the orthopedic device based on results of the risk analysis (388, 397) (Figs. 12A-B) (para [0204]), wherein the recommendation is directed to usage of the orthopedic device (386-388, 393, and 397) (Figs. 12A-B), wherein performing the risk analysis is characterized in that an evaluation unit (362) (Fig. 11) correlates data about the orthopedic device and/or comparable orthopedic devices and derives therefrom probabilities about malfunctions or disadvantageous effects and transmits these probabilities to the user, the orthopedic technician, the payer, and/or the producer (para [0159]) (also see para [0160] for context).
It would have been obvious to a skilled artisan to modify Oyen to include performing a risk analysis based on the evaluated sensor data; and displaying a recommendation to the user, a payer, an orthopedic technician, and/or a producer of the orthopedic device based on results of the risk analysis, wherein the recommendation is directed to usage of the orthopedic device, wherein performing the risk analysis is characterized in that the evaluation unit correlates data about the orthopedic device and/or comparable orthopedic devices and derives therefrom probabilities about malfunctions or disadvantageous effects and transmits these probabilities to the user, the orthopedic technician, the payer, and/or the producer, in view of the teachings of Hurley, for the obvious advantage of helping prevent injuries from potentially occurring in the future (see para [0143] of Hurley).
For claim 2, Oyen further discloses movement data, operating data, and/or loads of the orthopedic device or the sensor data about the user of the orthopedic device are acquired by the sensors (para [0036]).
For claim 3, Oyen further discloses the sensor data are acquired and processed in a chronologically limited manner or over an entire usage time period or usage time periods of the at least one orthopedic device (Examiner’s Note: “chronologically limited manner” and “entire usage time period or usage time periods” being implicit to para [0024] and [0036]).
For claim 4, Oyen further discloses supplementing the sensor data to be processed with assessments of the user of the orthopedic device and/or third parties (420) (Fig. 8) (para [0036] and [0072]).
For claim 6, Oyen further discloses the sensor data are transmitted in real time, during usage pauses, at defined times, on request of the evaluation unit, and/or by transmission by the user to the evaluation unit (para [0021]).
For claim 7, Oyen further discloses coding, prior to the transmitting, the sensor data in a personalized and/or device-specific manner (para [0065]).
For claim 8, Oyen further discloses the sensor data of various similar or comparable orthopedic devices of the user are compiled and processed in the evaluation unit (para [0065]).
For claim 9, Oyen further discloses the sensor data of comparable users or the sensor data of multiple users combined to form a group are acquired and processed in the evaluation unit (para [0065]).
For claim 11, Oyen, as modified, further discloses wherein the recommendation to the user is characterized in that usage instructions, warning messages, and/or requests (386-388, 393, and 397 of Hurley) (Figs. 12A-B of Hurley) are communicated to the user on a basis of the risk analysis (392 of Hurley) (Fig. 12B of Hurley).
For claim 12, Oyen further discloses wherein the orthopedic device and/or the storage unit comprise a control unit (338) (Fig. 7), which is coupled to a receiver (310) (Fig. 7), the method comprising: receiving, via the receiver, control data, access rights, sensor calibrations, and/or the changes thereof and/or recordings about changes associated with the orthopedic device (para [0036], [0060], and/or [0061]).
For claim 13, Oyen further discloses, calibrations, accesses to the sensor data, and access rights are stored and kept retrievable in the computer network (para [0069]).
Oyen does not expressly disclose settings, changes of settings are stored and kept retrievable in the computer network.
However, Hurley teaches settings, changes of settings are stored and kept retrievable in the computer network (para [0152]).
It would have been obvious to a skilled artisan to modify Oyen to include settings, changes of settings are stored and kept retrievable in the computer network, in view of the teachings of Hurley, because doing so would allow for the determination of whether or not changes made were helpful (see para [0152] of Hurley).
For claim 15, Oyen does not expressly disclose wherein the transmitter comprises a mobile terminal.
However, Hurley teaches wherein the transmitter comprises a mobile terminal (82, 84, 85) (Fig. 9A).
It would have been obvious to a skilled artisan to modify Oyen wherein the transmitter comprises a mobile terminal, in view of the teachings of Hurley, for the obvious advantage of allowing the user to make use of applications that facilitate the collection of qualitative data (see para [0145] of Hurley).
For claim 16, Oyen does not expressly disclose summaries of selected parameters which are acquired by the sensors or are derivable from the sensor data are transmitted to the user of the orthopedic device, the payer, the orthopedic technician, and/or the producer of the orthopedic device.
However, Hurley teaches summaries of selected parameters (494) (Fig. 21) which are acquired by the sensors or are derivable from the sensor data (51) (Fig. 5A) (para [0147]) are transmitted to the user of the orthopedic device, the payer, the orthopedic technician, and/or the producer of the orthopedic device (para [0228]) (also see 497 and Fig. 21).
It would have been obvious to a skilled artisan to modify Oyen to include summaries of selected parameters which are acquired by the sensors or are derivable from the sensor data are transmitted to the user of the orthopedic device, the payer, the orthopedic technician, and/or the producer of the orthopedic device, in view of the teachings of Hurley, for the obvious advantage of helping the user absorb and understand the data (see para [0228] of Hurley).
For claim 17, Oyen, as modified, further discloses a parameter curve is ascertained and displayed as the recommendation (494, Fig. 21, and para [0156] and [0228] of Hurley).
For claim 18, Oyen further discloses creating a specific data structure for the user and/or for the orthopedic device (para [0036] and [0065]); and selecting the sensor data to be acquired and/or transmitted to the evaluation unit based at least in part on the specific data structure (para [0036] and [0065]).
For claim 21, Oyen further discloses the transmitted sensor data and/or the evaluated sensor data are stored in a database (para [0065]).
For claim 22, Oyen further discloses an access to the evaluation unit and/or the computer network is restricted (para [0069]).
For claim 23, Oyen further discloses an orthosis, exoskeleton, or prosthesis is used as the orthopedic device (102) (Fig. 1) and the sensor data are acquired during the use of the orthosis, the exoskeleton, or the prosthesis (para [0021]).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Oyen in view of Hurley, and further in view of U.S. Patent Application Publication No. 2016/0143593 to Fu et al. (hereinafter “Fu”).
For claim 5, Oyen further discloses the assessments (420) (Fig. 8) are carried out on a basis of provided questions (para [0072]).
Oyen and Hurley do not expressly disclose wherein answers to the provided questions are transmitted to the evaluation unit in the computer network via a mobile terminal of the computer network.
However, Fu teaches wherein answers to provided questions (Fig. 11b) (para [0019]) are transmitted to the evaluation unit in the computer network (192) (Fig. 19) via a mobile terminal of the computer network (191) (Fig. 19).
It would have been obvious to a skilled artisan to modify Oyen wherein answers to the provided questions are transmitted to the evaluation unit in the computer network via a mobile terminal of the computer network, in view of the teachings of Fu, for the obvious advantage of helping provide better recommendations (see para [0025]-[0026] of Fu).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Oyen in view of Hurley, and further in view of U.S. Patent Application Publication No. 2017/0312153 to Paul et al. (hereinafter “Paul”).
For claim 14, Oyen and Hurley do not expressly disclose the orthopedic device is coupled with one or more other orthopedic devices, wherein the orthopedic device and the one or more other orthopedic devices exchange data via the computer network.
However, Paul teaches multiple orthopedic devices (1, 1’) (Fig. 1A) that are coupled to one another via a computer network (1050) (Fig. 11) and exchange sensor data (4, 4’) (Fig. 2).
It would have been obvious to a skilled artisan to modify Oyen such that the orthopedic device is coupled with one or more other orthopedic devices, wherein the orthopedic device and the one or more other orthopedic devices exchange data via the computer network, in view of the teachings of Paul, for the obvious advantage of helping inform the user of the device status and whether or not it is ready to be used (see para [0053] of Paul).
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Oyen in view of Hurley, and further in view of U.S. Patent Application Publication No. 2017/0027477 to Charles et al. (hereinafter “Charles”).
For claim 19, Oyen and Hurley do not expressly disclose selecting an alternative orthopedic device from multiple alternative orthopedic devices on a basis of the evaluated sensor data and/or the risk analysis, wherein the recommendation to the user, the orthopedic technician, and/or the payer comprises the selected alternative orthopedic device.
However, Charles teaches selecting an alternative orthopedic device from multiple alternative orthopedic devices on a basis of the evaluated sensor data and/or the risk analysis (Abstract), wherein the recommendation to the user, the orthopedic technician, and/or the payer comprises the selected alternative orthopedic device (Abstract).
It would have been obvious to a skilled artisan to modify Oyen to include selecting an alternative orthopedic device from multiple alternative orthopedic devices on a basis of the evaluated sensor data and/or the risk analysis, wherein the recommendation to the user, the orthopedic technician, and/or the payer comprises the selected alternative orthopedic device, in view of the teachings of Charles, for the obvious advantage of providing the user with a product with the best calculated fit and support for their needs (see para [0033] of Charles).
Response to Arguments
Applicant's arguments filed 8/6/26 have been fully considered but they are not persuasive. The main deficiency in the arguments presented in the response in that they are not commensurate in scope with the claim language. The arguments against Oyen are moot because Oyen is not relied upon for the argued claim language. But with respect to Hurley, claim 1 recites “malfunction or disadvantageous effects” (emphasis added). That is, the claim recites these two limitations in the alternative. The “malfunction” is not be relied upon in the rejection, but rather the “disadvantageous effect.” Additionally, the claimed “disadvantageous effect” is not tied to the orthopedic device. A careful examination of the claim language reveals that the claimed “evaluation unit” performs a correlation of “data about the orthopedic deice and/or comparable orthopedic devices.” But once the derivation step is recited, the “probabilities about malfunctions or disadvantageous effects” don’t have the similar claim limitation of “about the orthopedic device and/or comparable orthopedic device.” Therefore, the claimed “disadvantageous effect” can be about anything and still read on the claim language. It can be about the user’s foot, about the activity the user is performing, or even a goal that the user has. As a result, the response appears to be arguing a narrower scope that what is currently recited in the claim and allows for the risk of falling disclosed in Hurley to read on the claim language since falling would be a ”disadvantageous effect” for the user.
To make the argument(s) persuasive, the examiner humbly and respectfully suggests amending claim 1 to recite “derives therefrom probabilities about malfunction of the orthopedic device.” That makes it clear since the risk of falling taught in Hurley could not read on a malfunction of the orthopedic device.
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL LEE CERIONI whose telephone number is (313) 446-4818. The examiner can normally be reached M - F 8:00 AM - 5:00 PM PT.
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, Jennifer Robertson can be reached at (571) 272-5001. 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.
/DANIEL L CERIONI/Primary Examiner, Art Unit 3791
Prosecution Insights