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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/18/2025 has been entered.
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.
Claim(s) 1, 7, 9-12, 15, 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kania (2009/0132056A1) in view of Walter (10639173B2) and in view of Sanders (WO2014/130878).
In regard to claim 1, Kania teaches a prosthetic assembly (liner and socket) comprising:
a socket (socket, fig 23) comprising a first interlocking feature (void within socket for annular ring to fit, fig 23), the socket defining an inner volume (fig 23);
a liner (liner, fig 23) comprising a second interlocking feature (annular ring), wherein the first interlocking feature (socket void for annular ring, fig 23) and the second interlocking feature (annular ring, fig 23) are configured to engage each other when the liner is inserted into the inner volume of the socket (fig 23), the liner configured to receive a distal limb of a patient (fig 23).
However, Kania does not teach the socket or liner comprises a plurality of inner voids comprising internal channels for heat dissipation or a third set of internal channels including a passageway for electrical components in both the socket and the liner.
Walter teaches the liner comprise a plurality of inner voids (26, along proximal liner; Col 3, lines 25-30: pores distributed over entire liner surface) extending within walls of the liner (fig 4), wherein the plurality of inner voids 26 comprise a first set of internal channels for heat dissipation from the patient's distal limb to facilitate cooling of the patient's distal limb (capable if dissipating heat since the pores open to the outside of the liner as shown in figures 3-4),
a second set of internal channels (26 at distal liner, fig 4) for moisture evaporation from the patient's distal limb to facilitate evaporation of sweat or bodily fluids from the patient's distal limb (Col 2, lines 60-67).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the voids of Walter within the liner of Kania because they drain sweat. (Col 2, lines 60-67)
Sanders teaches a third set of internal channels for electrical components [0102: wires 606 run through grooves made in the insert], the third set of internal channels configured to receive at least one sensor or transducer and at least one myoelectric wire 604 [0102: sensing elements are flush with the surface and wires run through grooves; see fig 39B] , wherein a portion of at least one of the plurality of inner voids includes a passageway extending along a longitudinal length of the socket and the liner (see groove within which 606 fits in fig 39B), the passageway defined by a groove in at least one of the socket and the liner [0102: grooves]. [0021: device may be incorporated within the socket or within a liner]
It would have been obvious to one of ordinary skill in the art of prosthetics fabrication at the time the invention was filed to use the grooves including a passageway of Sanders in the socket and the liner of Kania because this allows embedded sensors to be used such as EMG, temperature or sweat detection sensors [0102] without creating pressure points within the socket and liner.
It is noted that in figures 13-14 of the instant invention the channel is formed by a groove in both the liner and socket simultaneously and connected directly to the external socket but that the current claim language does not convey this feature.
In regard to claim 7, Kania meets the claim limitations as discussed in the rejection of claim 1, and further teaches at least one of the socket or the liner comprises a variable thickness along a longitudinal length or radial direction of the socket or the liner. (fig 23, the liner has a variable thickness along its length and in the radial direction)
In regard to claim 9, Kania meets the claim limitations as discussed in the rejection of claim 1, and further teaches the prosthetic assembly is an above-the-knee or below-the-knee lower limb prosthetic assembly (as shown in figure 23, the socket is a below the knee assembly).
In regard to claim 10, Kania meets the claim limitations as discussed in the rejection of claim 1, and further teaches the prosthetic assembly is an above-the-elbow [0002: arm or leg]. Further, the socket of figure 23, is capable of being used as an above elbow socket due to the generic shape.
In regard to claim 11, Kania meets the claim limitations as discussed in the rejection of claim 1, wherein the socket is manufactured from a thermoplastic [0008] or a thermoplastic reinforced with carbon.
In regard to claim 12, Kania meets the claim limitations as discussed in the rejection of claim 1, wherein the liner is manufactured from a flexible silicone material [0073: silicones] or a rubber [0073: rubber; will be high durometer compared to some other rubber].
In regard to claim 15, Kania meets the claim limitations as discussed in the rejection of claim 1, and further teaches at least one of the liner or the socket comprise connection points configured to couple additional componentry to the prosthetic assembly. (see the distal pyramid adapter attached to the prosthetic socket, fig 23)
In regard to claim 17, Kania meets the claim limitations as discussed in the rejection of claim 1, but does not teach the protrusion is part of the socket and the void is part of the liner.
It has been held that a mere reversal of the working parts of an invention, yielding a predictable result, require no more than routine skill in the art. Accordingly, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to reverse the protrusion and void of Kania to put the protrusion on the socket and the void on the liner since it appears that either arrangement would work equally well. Absent a teaching of criticality (new or unexpected results), this arrangement is deemed to have been known by those skilled in the art at the time the invention was filed. MPEP 2144.04VIA
In regard to claim 18, Kania meets the claim limitations as discussed in the rejection of claim 1, wherein the first interlocking feature comprises a void (see fig 23, socket void within which annular ring fits) and the second interlocking feature (annular ring) comprises a protrusion (annular ring, fig 23), wherein the protrusion is configured to be received within the void to removably couple the socket with the liner. (fig 23)
In regard to claim 19, Kania meets the claim limitations as discussed in the rejection of claim 1, and further teaches the socket and the liner are configured to conform to an anatomical shape of the patient's distal limb. (see fig 23)
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kania (2009/0132056A1) in view of Walter (10639173B2) and in view of Sanders (WO2014/130878) and further in view of Wang (2013/0274896A1).
In regard to claim 5, Kania meets the claim limitations as discussed in the rejection of claim 1, but does not teach the electrical components as claimed.
Wang further teaches the electrical components comprise components of a Peltier cooling system. [0021: miniature thermoelectric devices]
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the cooling/sensor system of Wang in the liner of Kania, using the channels taught by Sanders which are applied to the liner of Kania for all electrical components, because the sensors provide early warning to the user of adverse events and the thermoelectric device controls temperature and sweat [0021]. The grooves of Sanders prevent electrical components from creating pressure points in the socket.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kania (2009/0132056A1) in view of Walter (10639173B2) and in view of Sanders (WO2014/130878) and further in view of Bause (WO2020/069817A1).
In regard to claim 6, Kania meets the claim limitations as discussed in the rejection of claim 1, but does not teach a fourth set of internal channels configured to provide therapy or medication to the patient’s distal limb.
Bause teaches the plurality of inner voids comprise a fourth set of internal channels configured to provide therapy or medication to the patient's distal limb. (page 4, paragraph 2 of translation: such channels…can also be used for the transport of medication).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the medication channels of Bause in the liner of Kania in order to provide treatment to a patient with an infection or other skin disorder.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kania (2009/0132056A1) in view of Walter (10639173B2) and in view of Sanders (WO2014/130878) and further in view of Orrasson (2021/0137708A1).
In regard to claim 8, Kania meets the claim limitations as discussed in the rejection of claim 1, but does not teach the liner comprises a lattice structure.
Orrasson teaches the liner comprises a lattice structure [0002; 0030], the lattice structure positioned at a distal end of the liner 326 and positioned between a double wall of the liner (fig 16), the lattice structure configured to facilitate desired transfer of forces between the prosthetic assembly and the patient's distal limb, to absorb impact forces, and to reduce shear stress (will be reduced compared to some other liner) Since the end structural limitations of apertures between the walls of the liner have been met, any inherent features such as the transfer of forces, absorbing impact forces and reducing sheer stress have also been met.
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the lattice structure of Orrasson at the distal end of the liner of Kania because this structure provides cushioning and structure while mitigating the buildup of heat and moisture [0016].
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kania (2009/0132056A1) in view of Walter (10639173B2) and in view of Sanders (WO2014/130878) and further in view of Egilsson (WO2015/073793A1).
In regard to claim 13, Kania meets the claim limitations as discussed in the rejection of claim 1, but does not teach a sealed vacuum section.
Egilsson teaches an exterior surface of the liner 321 and an internal surface of the socket are configured to engage each other to define sealed vacuum sections between the liner and the socket [10], wherein other sections of the liner and the socket do not define sealed vacuum sections (see above 321).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the seal band of Egilsson at the distal end of the liner of Kania in order to more positively secure the liner within the socket [10].
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kania (2009/0132056A1) in view of Walter (10639173B2) and in view of Sanders (WO2014/130878) and further in view of Einarsson (2007/0225824A1).
In regard to claim 14, Kania meets the claim limitations as discussed in the rejection of claim 1, wherein the prosthetic assembly is entirely manufactured through at least one of: additive manufacturing; or injection molding. [0078; 0119: liner is injection molded].
While Kania does not teach that the socket is made by injection molding, this is a product by process limitation, patentable only based on the resulting end structure. It appears that the end structure of an injection molded liner and socket would be the same as a noninjection molded liner and socket.
However, in the interest of compact prosecution, Einarsson teaches the use of injection molding to form a prosthetic socket [0054] and injection molding multiple prosthetic assembly components together [0054].
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to injection mold the prosthetic assembly of Kania as taught by Einarsson through functional equivalents since it appears either manufacturing method would work equally well. Absent a teaching of criticality (new or unexpected results), this arrangement is deemed to have been known by those skilled in the art at the time the invention was filed. MPEP 2144.06II
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kania (2009/0132056A1) in view of Walter (10639173B2) and in view of Sanders (WO2014/130878) and further in view of Schall (WO9840038A1).
In regard to claim 16, Kania meets the claim limitations as discussed in the rejection of claim 15, and while Kania teaches an endoskeletal pyramid adapter connected to the socket, Kania remains silent to how the pyramid adapter and socket are connected.
Schall teaches the connection points comprise an extrusion or a recess disposed on the liner or the socket. (see socket recesses which screws 46 fit within to attach the male pyramid in figures 5-6).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the male pyramid adapter of Schall (connection points) in place of the male pyramid adapter of Kania (connection points) because the adapter of Schall allows for offset and rotation adaptations (see fig 5) for greater alignment adjustability.
Claim(s) 45 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kania (2009/0132056A1) in view of Koniuk (2016/0184113A1).
In regard to claim 45, Kania teaches a prosthetic assembly, comprising:
a socket (socket, fig 23) comprising a first interlocking feature that is a void (cavity that fits annular ring, fig 23), the socket defining an inner volume (fig 23);
a liner (liner, fig 23) comprising a second interlocking feature that is a protrusion configured to be received within a void to removably couple the socket with the liner (annular ring, fig 23), wherein the first interlocking feature (cavity in socket, fig 23) and the second interlocking feature (annular ring) are configured to engage each other when the liner is inserted into the inner volume of the socket, the liner configured to receive a distal limb of a patient (fig 23).
However Kania does not teach the liner comprises a plurality of inner voids extending within the walls of the liner and teaches that the first interlocking feature is a cavity instead of a protrusion.
It has been held that a mere reversal of the working parts of an invention, yielding a predictable result, require no more than routine skill in the art. Accordingly, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to reverse the protrusion and void of Kania to put the protrusion on the socket and the void on the liner since it appears that either arrangement would work equally well. Absent a teaching of criticality (new or unexpected results), this arrangement is deemed to have been known by those skilled in the art at the time the invention was filed. MPEP 2144.04VIA
Koniuk teaches a portion of at least one of the plurality (defined as two or more) of inner voids 36 includes a passageway extending along a longitudinal length of the socket (fig 4) or the liner, the passageway 36 defined by a groove in at least one of an internal surface of the socket or the liner (see fig 4, the grooves are on the internal surface of the socket).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the grooves and vacuum suspension of Koniuk in the socket of Kania because this allows vacuum suspension to be applied and expands the surface area vacuum is applied for a better holding force [0030].
Claim(s) 46 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kania (2009/0132056A1) in view of Walter (10639173B2) and in view of Sanders (WO2014/130878) and further in view of Jonsson (10624767B2).
In regard to claim 46, Kania meets the claim limitations as discussed in the rejection of claim 1 but does not teach the internal channels as claimed.
Walter further teaches the first set of internal channels 26 or the second set of internal channels 26.
However, the combination of Kania in view of Walter does not teach an outlet through an external surface of the socket.
Jonsson teaches internal channels which include an outlet 111 through an external surface of the socket 75 (see figure 12).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the socket outlet of Jonsson in the socket of Kania because this permits the expulsion of fluid such as sweat or air from the socket (Col 12, lines 10-20). When the socket outlet of Jonsson is combined with the socket of Kania in view of Walter, the channels of the liner of Kania in view of Walter extend through the liner and therefore will be in communication with the distal socket as sweat and fluids will fall downwardly with gravity.
Response to Arguments
In regard to the 103(a) rejection of claims 1, 7, 9-12, 15 and 17-19 as unpatentable over Kania (2009/0132056A1) in view of Walter (10639173B2) and in view of Sanders (WO2014/130878), the applicant’s arguments have been fully considered but are directed towards new claim limitations which have been addressed above.
In regard to the 103(a) rejection of claim 5 as unpatentable over Kania (2009/0132056A1) in view of Walter (10639173B2) and in view of Sanders (WO2014/130878) and further in view of Wang (2013/0274896A1), no further arguments have been submitted.
In regard to the 103(a) rejection of claim 6 as unpatentable over Kania (2009/0132056A1) in view of Walter (10639173B2) and in view of Sanders (WO2014/130878) and further in view of Bause (WO2020/069817A1), no further arguments have been submitted.
In regard to the 103(a) rejection of claim 8 as unpatentable over Kania (2009/0132056A1) in view of Walter (10639173B2) and in view of Sanders (WO2014/130878) and further in view of Orrasson (2021/0137708A1) no further arguments have been submitted.
In regard to the 103(a) rejection of claim 13 as unpatentable over Kania (2009/0132056A1) in view of Walter (10639173B2) and in view of Sanders (WO2014/130878) and further in view of Egilsson (WO2015/073793A1) no further arguments have been submitted.
In regard to the 103(a) rejection of claim 14 as unpatentable over Kania (2009/0132056A1) in view of Walter (10639173B2) and in view of Sanders (WO2014/130878) and further in view of Einarsson (2007/0225824A1) no further arguments have been submitted.
In regard to the 103(a) rejection of claim 16 as unpatentable over Kania (2009/0132056A1) in view of Walter (10639173B2) and in view of Sanders (WO2014/130878) and further in view of Schall (WO9840038A1) no further arguments have been submitted.
In regard to the 103(a) rejection of claim 45-46 as unpatentable over Kania (2009/0132056A1) in view of Sanders (WO2014/130878), the applicant’s arguments have been fully considered. The applicant’s arguments are fully considered but are moot in view of new grounds of rejection as noted above.
Conclusion
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/CHRISTIE BAHENA/Primary Examiner, Art Unit 3774