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 05/29/26 have been fully considered but they are not persuasive.
On page 7 regarding claim objections Applicant argues amendments overcome the objections of record.
The Examiner respectfully notes the amendments which were addressed are overcome, but the ones which were not addressed, remain.
On page 8 regarding the specification and drawing objections Applicant argues amendments overcome the objections of record.
The Examiner respectfully agrees and withdraws drawing and specification objections.
On pages 8-9 regarding prior art rejections Applicant argues amendments incorporate allowable subject matter into the claims.
The Examiner respectfully notes prior art is now applied to these claims, based on the IDS filed with Applicant’s response.
Claim Objections
Claims 2 and 9 are objected to because of the following informalities:
Claim 2 is objected to for claiming “a measurement of anatomical three-dimensional shape”, when it appears a word is missing between “of” and “anatomical”.
The claim is further objected to for referring to “the compiled data set” with improper antecedent basis.
Claim 9 is objected to for referring to “the compiled data set” with improper antecedent basis.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 2-3, 6-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Watson et al. (US 6968246 B2 ) hereinafter known as Watson in view of Ezenwa (US 20080147204 A1), further in view of Zhang et al. “Finite element modelling of a residual lower-limb in a prosthetic socket: a survey of the development in the first decade.” Medical Engineering & Physics 20 (1998). Pages 360-373.), hereinafter known as Zhang, and further in view of Zachariah et al. “Automated Hexahedral Mesh Generation from Biomedical Image Data: Applicantions in Limb Prosthetics.” IEEE Transactions on Rehabilitation Engineering Vol 4 No 2, (June 1996). Pages 91-102.
Regarding claim 2 Watson discloses a method of fabricating a prosthetic mechanical interface comprising a liner (Figure 1 item 14) and a socket (Figure 1 item 16) for connecting a biological body segment to a wearable prosthetic device (Figure 1) comprising:
compiling a data set of features corresponding to the segment including a measurement of its anatomical 3d shape and a spatial representation of bone in the segment (Column 2 lines 14-17; Column 3 lines 25-26; Column 4 lines 35-37),
processing the data set to form a digital representation of the segment (Column 4 lines 41-43; Figure 7b item 76; a mapping of boney prominences is understood to be a digital representation of the underlying segment) and computing a digital representation from the digital representation of the segment (Figures 7b, 8b; Column 4 lines 45-48; Column 5 lines 63-65; a digital representation of the socket, overlay, and liner are modeled digitally based on the scanned data (although it is not clear if this is modeled at the same time to show the interface)),
fabricating the liner and socket based on the digital representation (Column 6 lines 1-2; Column 4 lines 58-61),
but is silent with regards to whether the interface is shown in a digital representation showing the inside surface of the socket with the liner disposed therein and contacting the socket’s inside surface,
and the data set of features further including one or more of viscoelasticity, skin tensile strain, and neural muscle activation.
However, regarding claim 2 Ezenwa teaches a method of manufacture of a prosthetic socket which includes measuring the pressure between the residual limb and socket, including a liner (Ezenwa claim 8; this includes the socket liner interface),
and Zhang teaches the interface between the residual limb and socket should have its pressure distribution modeled (which includes the liner interface as is taught by Ezenwa) (page 361 column 1 paragraph 2).
the interface between the socket and liner includes finite element analysis (FEA) (which inherently indicates a digital representation on a computer display).
Watson, Ezenwa, and Zhang are involved in the same field of endeavor, namely prosthetic socket manufacture. It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the method of Watson by showing the socket limb interface digitally as is taught by Zhang (and to have it include the liner at that interface as is taught by Ezenwa) in order to show a full picture of the socket system before manufacture, thus giving the prosthetist more information regarding its final appearance, function, and features while accounting for areas of high pressure.
Further, regarding claim 2 Zachariah teaches that skin tensile strain should be accounted for (see for example page 99 table IV which discusses the Young’s Modulus (tensile stress/strain) of skin) within a socket liner interface (page 91 first paragraph). Watson and Zachariah are involved in the same field of endeavor, namely leg prostheses. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the method of the Watson Ezenwa Zhang Combination to ensure data from the skin tensile strain is accounted for when manufacturing the interface as is taught by Zachariah since the breakdown of skin or soft tissue can be a large source of pain for an amputee, and taking it into account can prevent patient pain and so increase comfort and preserve existing tissues of the user.
Regarding claim 3 the Watson Ezenwa Zhang Zachariah Combination teaches the method of claim 2 substantially as is claimed,
wherein Watson further discloses the interface is a transtibial interface (Column 6 lines 42-43 a below the knee amputation indicates a transtibial interface).
Regarding claim 6 the Watson Ezenwa Zhang Zachariah Combination teaches the method of claim 2 substantially as is claimed,
wherein Watson further discloses the data set is compiled using surface scanning, CT, MRI, or ultrasound (Abstract).
Regarding claim 7 the Watson Ezenwa Zhang Zachariah Combination teaches the method of claim 2 substantially as is claimed,
wherein Zhang further discloses the method of socket manufacture should take into account tensile impedance at a plurality of anatomical points of the 3d shape (page 363 column 1 paragraph 2; fitting quality is determined by interfacial connecting stiffness or the ability of the interface to resist deformation; page 365 column 1 paragraph 1 soft tissues were meshed with different Young’s moduli in different regions, simulating the site-dependent stiffness of the tissues around the residual limb). It would have been obvious to one of ordinary skill at the time the invention was made to modify the method of the Combination to utilize tensile impedance as is taught by Zhang in order to provide as complete a profile of the underlying tissue as possible to take into account user comfort and anatomy.
Regarding claim 8 the Watson Ezenwa Zhang Zachariah Combination teaches the method of claim 2 substantially as is claimed,
wherein Watson further discloses the digital representation is made at a plurality of anatomical points (Figure 7b shows many points shown item 76); and the Combination teaches the representation being of the interface (see the rejection to claim 1 above).
Claims 4, 11, and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Watson, Ezenwa, Zhang, and Zachariah as is applied above, further in view of Schottdorf (US 20110161058 A1), and Caspers (US 20120173001 A1).
Regarding claim 4 the Watson Ezenwa Zhang Zachariah Combination teaches the method of claim 2 substantially as is claimed,
wherein Watson further discloses the spatial representation of bone includes a digital representation of a patella (Column 4 lines 35-36),
but is silent with regards to the spatial representation of bone including a digital representation of the femur, tibia, and fibula.
However, regarding claim 4 Schottdorf teaches that 3d image data acquired in order to manufacture a prosthesis can include information about the different tissues in the residual limb ([0016]), and Caspers teaches the residual limb can include bones such as the femur, tibia, and fibula ([0004], Figure 1).
Watson, Schottdorf, and Caspers are involved in the same field of endeavor, namely prosthetic sockets. It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the method of the Combination by viewing a digital representation of multiple bones within the leg including the tibia, fibula, and femur as is taught by Schottdorf and Caspers in order to ensure the entirety of the leg is accounted for in the planning of the manufacture of its prosthetic.
Regarding claim 11 the Watson Ezenwa Zhang Zachariah Schottdorf Combination teaches the method of claim 10 substantially as is claimed,
wherein Watson further discloses the spatial representation of bone includes a digital representation of a patella (Column 4 lines 35-36),
but is silent with regards to the spatial representation of bone including a digital representation of the femur, tibia, and fibula.
However, regarding claim 11 Schottdorf teaches that 3d image data acquired in order to manufacture a prosthesis can include information about the different tissues in the residual limb ([0016]), and Caspers teaches the residual limb can include bones such as the femur, tibia, and fibula ([0004], Figure 1).
Watson, Schottdorf, and Caspers are involved in the same field of endeavor, namely prosthetic sockets. It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the method of the Combination by viewing a digital representation of multiple bones within the leg including the tibia, fibula, and femur as is taught by Schottdorf and Caspers in order to ensure the entirety of the leg is accounted for in the planning of the manufacture of its prosthetic.
Regarding claim 13 the Watson Ezenwa Zhang Zachariah Schottdorf Combination teaches the method of claim 12 substantially as is claimed,
wherein Watson further discloses the spatial representation of bone includes a digital representation of a patella (Column 4 lines 35-36),
but is silent with regards to the spatial representation of bone including a digital representation of the femur, tibia, and fibula.
However, regarding claim 13 Schottdorf teaches that 3d image data acquired in order to manufacture a prosthesis can include information about the different tissues in the residual limb ([0016]), and Caspers teaches the residual limb can include bones such as the femur, tibia, and fibula ([0004], Figure 1).
Watson, Schottdorf, and Caspers are involved in the same field of endeavor, namely prosthetic sockets. It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the method of the Combination by viewing a digital representation of multiple bones within the leg including the tibia, fibula, and femur as is taught by Schottdorf and Caspers in order to ensure the entirety of the leg is accounted for in the planning of the manufacture of its prosthetic.
Claims 5, 9-10, 12, 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Watson, Ezenwa, Zhang, and Zachariah as is applied above, further in view of Schottdorf as is applied above.
Regarding claim 5 the Watson Ezenwa Zhang Zachariah Combination teaches the method of claim 2 substantially as is claimed,
but is silent with regards to the data set including soft tissue depth, tissue distribution, tissue density, and sensitivity.
However, regarding claim 5 Schottdorf teaches a method of socket manufacture which includes a scanned data set which includes soft tissue depth ([0011] layer thickness of skin fat muscle or bone), tissue distribution ([0016] distribution of tissue types of the stump), tissue density ([0016] tissue properties such as density), and sensitivity to external pressure influenced by the underlying anatomy of the segment ([0016] sensation of pain/pain sensitivity). Watson and Schottdorf are involved in the same field of endeavor, namely prosthetic sockets. It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the method of the Combination by utilizing the data features discussed by Schottdorf in order to ensure the maximum amount of information available is used in manufacturing a custom socket, thus increasing patient comfort.
Regarding claim 9 the Watson Ezenwa Zhang Zachariah Combination teaches the method of claim 2 substantially as is claimed,
wherein Watson further discloses employing surface scanning to compile the data set of features corresponding to the body segment (abstract),
and wherein Schottdorf further teaches employing a combination of surface scanning and CT, MRI, or ultrasound ([0004]) to compile the data set of features corresponding to the body segment. It would have been obvious to use a combination of multiple scanning mechanisms as is taught by Schottdorf in order to increase the accuracy and amount of data for the manufacture of the socket, thus leading to a more comfortable prosthesis for the patient.
Regarding claim 10 the Watson Ezenwa Zhang Zachariah Schottdorf Combination teaches the method of claim 9 substantially as is claimed,
wherein Watson further discloses the interface is a transtibial interface (Column 6 lines 42-43 a below the knee amputation indicates a transtibial interface).
Regarding claim 12 the Watson Ezenwa Zhang Zachariah Schottdorf Combination teaches the method of claim 9 substantially as is claimed,
wherein Watson further discloses the data set of features represents a measurement of the anatomical 3d shape of the segment and a spatial representation of bone in the segment (Column 2 lines 14-17; Column 3 lines 25-26; Column 4 lines 35-37).
Regarding claim 14 the Watson Ezenwa Zhang Zachariah Schottdorf Combination teaches the method of claim 9 substantially as is claimed,
wherein Zhang further teaches compiling the data set comprises employing electromechanical measurement tools (page 367 column 1 paragraph 1). It would have been obvious to use an electromechanical tool as is taught by Zhang in order to increase the accuracy and amount of data for the manufacture of the socket, thus leading to a more comfortable prosthesis for the patient.
Regarding claim 15 the Watson Ezenwa Zhang Zachariah Combination teaches the method of claim 9 substantially as is claimed,
but is silent with regards to the data set including soft tissue depth, tissue distribution, tissue density, and sensitivity.
However, regarding claim 15 Schottdorf teaches a method of socket manufacture which includes a scanned data set which includes soft tissue depth ([0011] layer thickness of skin fat muscle or bone), tissue distribution ([0016] distribution of tissue types of the stump), tissue density ([0016] tissue properties such as density), and sensitivity to external pressure influenced by the underlying anatomy of the segment ([0016] sensation of pain/pain sensitivity). Watson and Schottdorf are involved in the same field of endeavor, namely prosthetic sockets. It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the method of the Combination by utilizing the data features discussed by Schottdorf in order to ensure the maximum amount of information available is used in manufacturing a custom socket, thus increasing patient comfort.
Conclusion
Applicant's submission of an information disclosure statement under 37 CFR 1.97(c) with the timing fee set forth in 37 CFR 1.17(p) on 05/29/26 prompted the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 609.04(b). 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 Jacqueline Woznicki whose telephone number is (571)270-5603. The examiner can normally be reached M-Th 10am-6pm EST.
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/Jacqueline Woznicki/Primary Examiner, Art Unit 3774 06/10/26
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