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 06/01/2026 have been fully considered but they are not persuasive.
Regarding the amendments to the claims, newly-found reference of Alley has been introduced. Alley teaches that the technician manually applies pressure to the patient’s limb. Examiner upholds that the combination of Herr and Alley teach the full scope of the independent claims.
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 1-5, 7-10, 13, & 21 rejected under 35 U.S.C. 103 as being unpatentable over Herr (US 2021/0145608) in view of Alley (US 2018/0293333).
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]);
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]), wherein distances and/or relative positions between at least 100 points are detected (Figure 19); and
recording the contour of the modified shape of the limb ([0432]).
However, Herr fail to disclose manually manipulating, by a technician who is not the prosthetic wearer, a shape of the limb to define a modified shape of the limb, wherein the technician pre-compresses the limb to shape at least one specific area of the limb into the modified shape, wherein the modified shape corresponds to a shape the limb is intended to assume in a prosthetic socket, and wherein the technician applies targeted pressure to the at least one specific area of the limb to redistribute soft tissue relative to underlying bony structures of the limb.
Alley teaches manually manipulating ([0005] & [0021]), by a technician who is not the prosthetic wearer (plaster technician, [0005]/cast taker, [0021]/prosthetist or clinician, [0102]/technician, [0120]), a shape of the limb to define a modified shape of the limb ([0005]), wherein the technician pre-compresses the limb ([0021]) to shape at least one specific area of the limb into the modified shape ([0005] & [0120]), wherein the modified shape corresponds to a shape the limb is intended to assume in a prosthetic socket (socket 202, [0116]), and wherein the technician applies targeted pressure to the at least one specific area of the limb ([0005], [0021], [0102], & [0120]) to redistribute soft tissue relative to underlying bony structures of the limb ([0005]).
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 (i.e., any device that can measure the shape of the limb at rest can measure the shape of the compressed limb). Herr teaches in [0442] that data can be obtained while the technician is applying forces to the sheath, and, thus, changing its shape. Likewise, the sheath would still be able to obtain data while the technician of Alley is compressing the limb. Nevertheless, Alley teaches in [0087] that image data can be obtained during compression of the limb.
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 method of Herr to include manually manipulating, by a technician who is not the prosthetic wearer, a shape of the limb to define a modified shape of the limb, wherein the technician pre-compresses the limb to shape at least one specific area of the limb into the modified shape, wherein the modified shape corresponds to a shape the limb is intended to assume in a prosthetic socket, and wherein the technician applies targeted pressure to the at least one specific area of the limb to redistribute soft tissue relative to underlying bony structures of the limb, as taught by Alley. Compressing the limb into the shape it will take in the prosthetic socket will ensure a better fit and be more comfortable for the patient.
Regarding claim 2, Herr in view of Alley teach the method of claim 1, and Herr further teaches that 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 in view of Alley teach the method of claim 2, and Herr further teaches that 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 in view of Alley teach the method of claim 3, and Herr further teaches that the measuring radiation is sonic waves, such as ultrasonic waves ([0418]).
Regarding claim 5, Herr in view of Alley teach the method of claim 3, and Herr further teaches that the enveloping body comprises more than one receiver (Figure 19/[0418], see rejection of claim 3).
Regarding claim 7, Herr in view of Alley teach the method of claim 1, and Herr further teaches that the at least one sensor is a shape sensor (curvature sensors 24, [0428]).
Regarding claim 8, Herr in view of Alley teach the method of claim 1, and Herr further teaches that 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 in view of Alley teach the method of claim 1, and Herr further teaches that the base body is made from an elastic material (elastomeric material, [0426]).
Regarding claim 10, Herr in view of Alley teach the method of claim 1, and Herr further teaches that the enveloping body is a prosthesis liner (socket liner 12’, [0445]) and the base body is made of a liner material ([0446]-[0447]).
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. Likewise, Alley teaches in [0087] that image data can be obtained during compression of the limb. In this instance, the modified shape of the limb is maintained during data capture.
Claims 6 & 14 are rejected under 35 U.S.C. 103 as being unpatentable over Herr in view of Alley, as applied to claim 1, above, in view of Sanders (US 2015/0359644).
Regarding claim 6, Herr in view of Alley teach the method of claim 1.
However, Herr in view of Alley fail 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 and Alley 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 in view of Alley teach the method of claim 1.
However, Herr in view of Alley fail 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 and Alley 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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 ADAM KOLKIN whose telephone number is (571)272-5480. The examiner can normally be reached Monday-Friday 1:00PM-10:00PM EDT.
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, 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.
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.
/ADAM D. KOLKIN/Examiner, Art Unit 3798
/KEITH RAYMOND/Supervisory Patent Examiner, Art Unit 3798
Prosecution Insights