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 .
Response to Arguments
Applicant's arguments filed 12/29/2025 have been fully considered but they are not persuasive.
Regarding the amendments to the claims, Examiner upholds the use of Herr to teach that the technician pre-compresses the limb into the modified shape. The compression caused by the elastomeric sheath of Herr is constantly maintained as it is worn by the user, including during the shape-recording process. The sheath can be applied by the technician, and this compression reads on the claimed pre-compression. Additionally, the forces applied by the technician using the fingers or probe (detailed in [0442] of Herr) can similarly read on the pre-compression. If these forces are applied prior to the capturing of the data, then the limb is pre-compressed by the technician into the modified shape when the shape is recorded. Thus, the use of Herr is maintained.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-5, 7-10, 13, & 21 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Herr (US 2021/0145608).
Regarding claim 1, Herr teaches a method for at least partially recording a contour of a limb (biological body segment 18, [0426]) of a prosthetic wearer (user, [0426]), wherein the method comprises the steps of:
providing an enveloping body (3D measuring device 10, [0426]), the enveloping body comprising a base body (elastomeric sheath 12, [0426]) and at least one sensor (plurality of transducers, [0427]/stretch sensors 22 & curvature sensors 24, [0428]/ultrasonomicrometry crystals 49, [0437]), the at least one sensor being configured to record measurement data to determine a distance and/or relative position between two points in or on the base body ([0427], [0429], [0432], & [0437]);
mounting the enveloping body on the limb of the prosthetic wearer ([0426]);
manually manipulating, by a technician (medical professional, [0439]) who is not the prosthetic wearer ([0439] & Figure 19), a shape of a limb to define a modified shape of the limb ([0442]), wherein the technician pre-compresses the limb to shape at least one specific area of the limb into the modified shape ([0442]);
Paragraph [0442] teaches that forces can be applied to each node of the sheath by either the fingers or the probe 44; these forces would change the shape of the limb. Additionally, the elastomeric sheath would provide a compressive force to the limb and, if so desired, can be applied by the technician. This, in addition to the technician applying the forces, can constitute a pre-compression.
recording measurement data of the modified shape of the limb by means of the at least one sensor ([0427], [0429], [0432], & [0437]) while the technician is manually manipulating the shape of the at least one specific area of the limb into the modified shape ([0439] & [0442]);
Paragraphs [0429] & [0437] teach that the distance between the nodes 14 can be measured. Applying forces to the nodes (as is taught in [0439] & [0442]) would change the distances between them.
determining distances and/or relative positions between two points in or on the base body ([0427], [0429], [0432], & [0437]) in an electric data processing device (thin-film microcontroller 36, [0434]) while the technician is manually manipulating the shape of the at least one specific area of the limb into the modified shape ([0439] & [0442]); and
recording the contour of the modified shape of the limb ([0432]).
Regarding the “recording” steps, there is no functional difference between recording the measurement data or contour of the original shape of the limb versus the modified shape of the limb. Thus, these steps can be applied to the modified shape of the limb regardless of whether Herr explicitly teaches such.
Regarding claim 2, Herr teaches the method of claim 1, wherein the at least one sensor has a transmitter (transmitter crystal, [0418]) for a measuring radiation (acoustic signals, [0418]) and a receiver (receiver crystal, [0418]) for the measuring radiation ([0418]), which are arranged in such a way that the measuring radiation emitted by the transmitter is at least partially received by the receiver (Figure 19/[0418]).
Regarding claim 3, Herr teaches the method of claim 2, wherein the transmitter is located at a first point and the receiver at a second point (Figure 19/[0418]).
Figure 19 shows that the base body has a grid of nodes comprising the sensors. Any node can be considered “the transmitter” and any and all other nodes can be considered “the receiver”. Alternatively, [0418] teaches “A single omnidirectional transmitter crystal may send a signal to multiple receiver crystals”.
Regarding claim 4, Herr teaches the method of claim 3, wherein the measuring radiation is sonic waves, such as ultrasonic waves ([0418]).
Regarding claim 5, Herr teaches the method of claim 3, wherein the enveloping body comprises more than one receiver (Figure 19/[0418], see rejection of claim 3).
Regarding claim 7, Herr teaches the method of claim 1, wherein the at least one sensor is a shape sensor (curvature sensors 24, [0428]).
Regarding claim 8, Herr teaches the method of claim 1, wherein the enveloping body features a communication interface by means of which the measurement data recorded by the at least one sensor can be transmitted to an electronic data processing device ([0434]), in particular a micro-processor (thin-film microcontroller 36, [0434]).
Regarding claim 9, Herr teaches the method of claim 1, wherein the base body is made from an elastic material (elastomeric material, [0426]).
Regarding claim 10, Herr teaches the method of claim 1, wherein the enveloping body is a prosthesis liner (socket liner 12’, [0445]) and the base body is made of a liner material ([0446]-[0447]).
Regarding claim 13, Herr teaches the method of claim 1, wherein the distances and/or relative positions between at least 100 points are detected (Figure 19).
Claim 21 is rejected for similar reasons to claim 1. Herr further teaches manually maintaining, by the technician, the modified shape of the limb during the process of recording measurement data of the modified shape of the limb by means of the at least one sensor ([0442]);
If so desired, the medical professional can maintain the forces applied by the fingers or probe 44 in [0442] during the data collection.
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 6 & 14 are rejected under 35 U.S.C. 103 as being unpatentable over Herr, as applied to claim 1, above, in view of Sanders (US 2015/0359644).
Regarding claim 6, Herr teaches the method of claim 1.
However, Herr fails to disclose that the at least one sensor comprises a strain sensor, in particular a strain gauge.
Sanders teaches that the at least one sensor (one or more sensors 106, [0107]) comprises a strain sensor, in particular a strain gauge (strain-gage plethysmography device, [0107]).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the enveloping body taught by Herr such that the at least one sensor comprises a strain sensor, in particular a strain gauge, as taught by Sanders. The strain-gage incorporated into the enveloping body would measure a change in a volume of the limb, allowing for a better and more comfortable fit to be achieved.
Regarding claim 14, Herr teaches the method of claim 1.
However, Herr fails to disclose that the recording of the measurement data is continuous.
Sanders teaches that the recording of the measurement data is continuous ([0099]).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modify the enveloping body taught by Herr such that the recording of the measurement data is continuous, as taught by Sanders. Because the position of the limb is expected to change throughout the day, a continuous recording of data can determine the quality of fit for all positions a patient may place their limb.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADAM KOLKIN whose telephone number is (571)272-5480. The examiner can normally be reached Monday-Friday 1:00PM-10:00PM EDT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith Raymond can be reached on (572)-270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ADAM D. KOLKIN/Examiner, Art Unit 3798
/KEITH M RAYMOND/Supervisory Patent Examiner, Art Unit 3798