DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. 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
2. Applicant’s election of ORTHOPAEDIC DEVICE - Species A (embodied in Figure 1) in the reply filed on 30 June 2026 is 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)).
3. Applicant’s election of CROSS-SECTION OF DEVICE - Species A (embodied in Figure 1a) in the reply filed on 30 June 2026 is 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)).
4. Applicant’s election of ACTUATION ELEMENT - Species A - single actuation element (Figures 1, 1a) in the reply filed on 30 June 2026 is 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)).
5. Applicant’s election of SENSOR - Species A (embodied in Figure 1a) in the reply filed on 30 June 2026 is 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)).
6. Applicant’s election of DRIVE - Species B (embodied in Figure 3 - right-hand drawing - manual adjustment) in the reply filed on 30 June 2026 is 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)).
7. According to Applicant’s response – “Claims which read on all of the elected species include claims 1-5 and 7- 10 and method claims 11-14”.
Priority
8. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Specification
9. The abstract of the disclosure is objected to because it should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Rejections - 35 USC § 102
10. 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.
11. Claims 1, 2, and 4-14 rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Will et al. (US PG Pub No. 2019/0183663 A1; cited in Applicant’s IDS).
Regarding independent claim 1, and referring to Figures 1-4 and 7-9, Will et al. ‘663 teaches an orthopaedic device, comprising:
at least one wall (socket 1 by itself; or wall segments/elements 5, 6, 7, and/or 8) which at least partially surrounds a stump or limb when fitted (Abstract), wherein the wall has a variable inner periphery (Abstract; [0011], [0012], [0015], [0037], [0040], [0041], [0042], [0057], [0059], [0076], [0077], [0079], [0085], [0086]) and forms an entry opening (3);
an actuator (actuator/motor 41, 42, and/or 43) mounted on the orthopaedic device for at least one actuation element (cords/cables 11, 12, and/or 13) which is mounted on the orthopaedic device, wherein the actuator is usable to vary the inner periphery of the at least one wall (Abstract; [0011], [0012], [0015], [0037], [0040], [0041], [0042], [0057], [0059], [0076], [0077], [0079], [0085], [0086]); and
at least one sensor device (sensors 30, 31, 32, 33, 35, and/or 44) assigned to (i.e., functionally, directly or indirectly) a mounting of the actuator and/or a mounting of the at least one actuation element, wherein the at least one sensor device determines mounting forces of the actuator and/or of the actuation element ([0016], [0028], [0029], [0032], [0037], [0063]-[0067], [0070]-[0079], and [0083]).
Regarding claim 2, Will et al. ‘663 teaches wherein the actuator, the at least one actuation element, and/or a diverting device (22) assigned to the at least one actuation element is mounted in floating fashion (compare Figure 2 to Figure 3; compare Figure 8 to Figure 9) on the orthopaedic device, and wherein the at least one sensor device is configured to detect a load-dependent displacement ([0016], [0028], [0029], [0032], [0037], [0063]-[0067], [0070]-[0079], and [0083]).
Regarding claim 4, Will et al. ‘663 teaches where the at least one sensor device is designed or arranged to detect forces acting in a proximal-distal direction, in a radial direction, and/or in a peripheral direction of the at least one wall ([0016], [0028], [0029], [0032], [0037], [0063]-[0067], [0070]-[0079], and [0083]).
Regarding claim 5, Will et al. ‘663 teaches wherein the at least one actuation element is designed as a flexible traction element ([0059], [0066]).
Regarding claim 6, Will et al. ‘663 teaches wherein the actuator comprises a slide ([0076]), a spindle ([0076]), or a roller (Figures 7-9 – roller 46 + actuator/motor 41), wherein the slide, the spindle, or the roller is connected to the at least one actuation element (Figures 7-9).
Regarding claim 7, Will et al. ‘663 teaches wherein the at least one wall is formed in multiple parts or is divided into segments (5, 6, 7, and/or 8) that are displaceable relative to one another (Abstract; [0011], [0012], [0015], [0037], [0040], [0041], [0042], [0057], [0059], [0076], [0077], [0079], [0085], [0086]).
Regarding claim 8, Will et al. ‘663 teaches wherein the actuator is driven by a motor (motor 41, motor 42, and/or motor 43) or is driven manually.
Regarding claim 9, Will et al. ‘663 teaches wherein the at least one sensor device is connected to a control device (40) which activates and/or deactivates a motor drive (motor 41, motor 42, and/or motor 43) of the actuator based on sensor values ([0011], [0012], [0028], [0037], [0039], [0063], [0065], [0067], [0070], [0077]) and/or the control device transmits a display or output command to a display or output device ([0032]).
Regarding claim 10, the figures of Will et al. ‘663 clearly show wherein the device is designed as a prosthesis socket, an orthosis, or an exoskeleton.
Regarding claim 11, Will et al. ‘663 teaches a method (claim 19) for controlling an adaptation of an inner periphery of a wall of an orthopaedic device as claimed in claim 1 comprising detecting sensor values undershot ([0011], [0012], [0028], [0037], [0039], [0063], [0065], [0067], [0070], [0077]) by the at least one sensor device, and activating or deactivating a drive (motor 41, motor 42, and/or motor 43) of the actuator if set threshold values are overshot and/or undershot ([0011], [0012], [0028], [0037], [0039], [0063], [0065], [0067], [0070], [0077]).
Regarding claim 12, Will et al. ‘663 teaches further comprising defining different threshold (e.g., preset or predetermined) values for different usage situations (sports activities – [0012], [0039], [0077]), and either automatically identifying a particular usage situation based on the sensor values or manually selecting the particular usage situation ([0012], [0028], [0037], [0039], [0063], [0065], [0067], [0070], [0077]). Notice, this subject matter is the result of routine methods that a person skilled in the art would apply, according to particular circumstances of the patient, without exercising inventive skill.
Regarding claim 13, Will et al. ‘663 teaches wherein the sensor values are ascertained at different points on the orthopaedic device ([0016], [0028], [0029], [0032], [0037], [0063]-[0067], [0070]-[0079], and [0083]). Notice, this subject matter is the result of routine methods that a person skilled in the art would apply, according to particular circumstances of the patient, without exercising inventive skill.
Regarding claim 14, Will et al. ‘663 teaches further comprising detecting mounting forces of the actuator and/or of the at least one actuation element at mounting points (the “mounting points” are NOT defined in the claim language, and are therefore broadly interpreted to read on any of the wall segments) of the actuator ([0016], [0028], [0029], [0032], [0037], [0063]-[0067], [0070]-[0079], and [0083]) and/or of the at least one actuation element in real time (e.g., during a sports activity - [0012], [0039], [0077]) and/or irrespective of an operating state of the actuator
Claim Rejections - 35 USC § 103
12. 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 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.
13. Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Will et al. (US PG Pub No. 2019/0183663 A1; cited in Applicant’s IDS) in view of Laszczak et al. (WO 2019/048877 A1).
Regarding claim 3, Will et al. ‘663 discloses the invention as claimed, including, wherein the at least one sensor device has at least one sensor which detects distances, spacings, forces. and/or moments ([0016], [0028], [0029], [0032], [0037], [0063]-[0067], [0070]-[0079], and [0083]), except for particularly disclosing wherein the at least one sensor device is designed as a piezo element, capacitive sensor, resistive sensor, inductive displacement transducer, inductive spacing sensor, or optical sensor.
However, this is already known in the art. For example, Laszczak et al. ‘877 teaches an orthopaedic device (Abstract and Figure 1A) comprising at least one sensor device designed as a piezo element, capacitive sensor, resistive sensor, inductive displacement transducer, inductive spacing sensor, or optical sensor (page 23, line 14 to page 25, line 14) in order to provide an adjustable orthopaedic device with better control of the fit and comfort to the user (page 23, lines 4-13).
Therefore, it would have been obvious to a person of ordinary skill in the art at the time of the effective filing date of the claimed invention to have combined the teaching of wherein the at least one sensor device is designed as a piezo element, capacitive sensor, resistive sensor, inductive displacement transducer, inductive spacing sensor, or optical sensor, as taught by Laszczak et al. ‘877, with the invention of Will et al. ‘663, in order to provide an adjustable orthopaedic device with better control of the fit and comfort to the user.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Examiner Javier G. Blanco whose telephone number is (571)272-4747. The examiner can normally be reached on M- F (10am-7:30pm).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, SPE Jerrah C. Edwards, at (408) 918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JAVIER G BLANCO/ Primary Examiner, Art Unit 3774