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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 6 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In regard to claim 6, the claim recites an improper Markush group, rendering the scope of the claim definite. The claim recites the suspension systems in the format “configurable as one of A, B, C and D”. The claim should be written as “selected from the group consisting of A, B, C, and D” or written as “selectively configurable as one of A, B, C, or D”.
Since claims 7 and 20 depend from claim 6 they are also rejected under 112b.
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) 1-2, 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Slemker (6287345B1) in view of Dallos (2005/0267600A1) and in view of Lundt (WO95/25488).
In regard to claim 1, Slemker teaches a prosthetic system, comprising:
a prosthetic socket (fig 1) configured to enclose at least a portion of a residual limb (within 24), the prosthetic socket (fig 1) comprising a top end comprising a cup (12; fig 9; claim 10: shaped for receiving a patient’s limb)
suspension systems 10 configured to be installed on the bottom end of the prosthetic socket (fig 1, at the bottom of 12) wherein the suspension systems 10 are interchangeable and sized to fit substantially within the recess portion of the base, and wherein the suspension systems are selected from the group consisting of:
(i) a vacuum suspension system without release;
(ii) a vacuum suspension with a release
(iii) a suction suspension system 10 (abstract)
and (iv) a pin lock suspension system comprising a plunger pin; a bridge comprising a first leg portion having a first base plug and a second leg portion having a second base plug, wherein the first base plug and the second base plug are configured to be plugged into a base opening formed at the bottom end of the prosthetic socket for mounting the pin lock suspension system onto the bottom end of the prosthetic socket.
However, Slemker does not teach a base plate which is adjustable in the coronal and saggital directions, the base or that the socket is a conical shape or the use of 4 different suspension systems.
Lundt teaches the prosthetic socket 44 comprising a bottom end comprising a base 46 (fig 3) including a recess portion extending from an end portion of the base to a top portion of the base (as shown in figure 3, 44 fits within 46 and therefore 46 has a recess for the socket to fit into; 46 is taught as a cup shaped adapter and a cup is hollow).
It would have been obvious to one of ordinary skill in the art at the time the invention was file to use the base of Lundt on the bottom end of the socket of Slemker because this will reinforce the distal end of the socket.
Dallos teaches a base plate assembly (fig 1) configured to retain each of the selected suspension systems (connects external to the socket, to the internal base plate when combined with Slemker) and to couple the prosthetic socket to a mechanical leg extension in an adjustable manner adjusting an alignment of the mechanical leg extension in coronal and sagittal plane orientations (see figure 1, connects to leg extension 14 in figure 1).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the base plate of Dallos in the socket of Slemker because the device allows greater alignment adjustability (abstract; fig 2).
It has been held that a mere change in shape of the working parts of the invention, yielding a predictable result, requires 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 make the socket shape of the socket of Slemker conical, in order to customize the shape to a conical limb. 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 2144.04IVB
Based on the dependent claims (for example claim 5), as best understood, it does not appear that independent claim 1 requires “different suspension systems” to refer to different types of suspension, only an additional suspension systems. If it is intended to positively recite each of the 4 different types of suspension systems, the claim language should be changed to clarify this.
It has been held that a mere duplication of the working parts of an invention, yielding a predictable result, requires 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 have additional suspension systems (at least 4) available to use for multiple patients or incase repair is needed. Absent a teaching of criticality (new or unexpected results), this arrangement is deemed to have been known by those skilled in the art a the time the invention was filed. MPEP 2144.04IVB
In regard to claim 2, Slemker meets the claim limitations as discussed in the rejection of claim 1, but does not teach the base plate assembly as claimed.
Dallos further teaches wherein the base plate assembly comprises:
a pyramid base 52; a base cover 22; a base plate 20 with a plurality of alignment features (dovetails, screws, fig 3-4); and a bolt ring 69.
Claim(s) 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Slemker (6287345B1) in view of Dallos (2005/0267600A1) and in view of Lundt (WO95/25488) and in view of Coppens (WO2008/116025A2).
In regard to claim 6, Slemker teaches a prosthetic system configured to receive different suspensions systems (capable of due to the use of standard endoskeletal componentry and since the system is removable as evidenced by screws 70), comprising:
a prosthetic socket (fig 1) comprising a cup 12 (fig 3)
a suspension system 10 configured to be installed on the prosthetic socket (fig 1),
a suspension system 10 configured to be installed on the prosthetic socket (fig 1), the suspension system 10 is interchangeable and sized to fit substantially within the recess portion of the base (fits within the socket and therefore the base as noted in the modified claim below)
wherein the suspension system 10 is selected from the group consisting of:
to a vacuum suspension system without a release (capable of being used in conjunction with a vacuum pump since the system seals; see abstract),
a vacuum suspension with a release (capable of being used in conjunction with a vacuum pump since the one way valve 92 only lets out air and the system seals, abstract),
a suction suspension system 10 (abstract)
and a pin lock suspension system.
The bottom of the socket is configured to be interchangeably mounted to any suspension system with a 4 hole adapter. The suspension systems are not laminated into socket therefore interchangeable, see fig 3, pops off)
However, Slemker does not teach a base plate assembly, that the socket is a conical shape, the socket base and remains silent to the socket material.
Dallos teaches a base plate assembly (fig 1) configured to retain the suspension system (connects external to the socket, to the internal base plate when combined with Slemker; the screws in Slemker would be used to attached the plate of Dallos when the systems are combined as shown in fig 1 of Slemker) and to couple the prosthetic socket to a mechanical leg extension (pylon 14, fig 1) in an adjustable manner adjusting an alignment of the mechanical leg extension in coronal and saggital plane orientations (moves in both planes, see perpendicular dovetails 34 and 36 in figure 1).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the base plate of Dallos in the socket of Slemker because the device allows greater alignment adjustability (abstract; fig 2).
It has been held that a mere change in shape of the working parts of the invention, yielding a predictable result, requires 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 make the socket shape of the socket of Slemker conical, in order to customize the shape to a conical limb. 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 2144.04IVB
Lundt teaches the prosthetic socket 44 comprising a bottom end comprising a base 46 (fig 3) comprising a recess portion 48. The base is concave around the outer distal socket and will therefore encompass the suspension system in the distal end of the socket when combined with Slemker.
It would have been obvious to one of ordinary skill in the art at the time the invention was file to use the base of Lundt on the bottom end of the socket of Slemker because this will reinforce the distal end of the socket.
Coppens teaches a socket that comprises a material (thermoplastic [0009]) configured to have a first pliability at a first temperature range [0009: formable between 50 and 80 degrees Celcius), a second pliability at a second temperature range (not pliable below 50 degrees Celcius [0009]), wherein the second pliability is different from the first pliability, and configured to be stretched circumferentially over a residual limb or a model of a residual limb when the material has a first pliability (capable of since formable; [0009]).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the thermoplastic of Coppens to fabricate the socket of Slemker because the low temperature formability allows the socket to be direct contact molded or adjusted on the patient (abstract).
In regard to claim 7, Slemker meets the claim limitations as discussed in the rejection of claim 6, but does not teach the base plate as claimed.
Dallos further teaches wherein the base plate assembly comprises:
a pyramid base 52; a base cover 22; a base plate 20 with a plurality of alignment features (dovetails, screws, fig 3-4); and a bolt ring 69.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Slemker (6287345B1) in view of Dallos (2005/0267600A1) and in view of Lundt (WO95/25488) and further in view of Bouch (WO2014/035561A1).
In regard to claim 4, Slemker meets the claim limitations as discussed in the rejection of claim 1, and further teaches the suction suspension system 10 is sized to substantially fit within the base of the prosthetic socket (fit within the bottom of the socket 12 as shown in figure 1) and the suspension system 10 mounted on the bottom of the prosthetic socket (fig 1) comprises the suction suspension system 10 (see figure 1, on the bottom of the socket) and the suction suspension system 10 is configured to secure the prosthetic socket (fig 1) to at least the portion of the residual limb 24 (abstract) by allowing air to escape through a one-way valve (check valve; Col 5, lines 47-53) as the residual limb is inserted into the prosthetic socket, and subsequently sealing the socket not allowing air to escape and thereby creating a vacuum to hold the residual limb in the socket, (the suction suspension system).
However, Slemker does not teach the check valve is elastomeric.
Bouch teaches a prosthetic valve that is elastomeric (description: elastomeric valve).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the one way valve of Bouch in place of the check valve of Slemker since they are functional equivalents and it appears that either valve would function equally well. Absent at 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) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Slemker (6287345B1) in view of Dallos (2005/0267600A1) and in view of Lundt (WO95/25488) and further in view of Rush (2005/0240282A1) and further in view of King (2007/0055383A1).
In regard to claim 5, Slemker meets the claim limitations as discussed in the rejection of claim 1, and further teaches the suspension system comprises a vacuum system without release or a vacuum suspension with release (this covers all options) and wherein the vacuum suspension system (Col 9, lines 5-15: check valve to close, which in combination with the seal formed by the O-ring forms a vacuum within the socket interior) and a hose connection (see valve duct 60 or disconnect port 64 which are both connected to the valve 58) and a channel (see channel 20) but does not teach the use of a filter or that the hose connection is a barb.
Rush teaches the vacuum suspension system comprises a filter placed on top (on top could be any direction depending on the orientation of the device) of the vacuum hose barb within the vacuum channel, the filter configured to prevent particles from entering into the prosthetic socket. [0069: valve including an integral filter]
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the filter of Rush within the valve of Slemker (which is in a channel and hose barb) because the filter prevents any dirt or debris from clogging the valve (purpose of a filter).
King teaches the use of a hose barb in a prosthetic suspension system. [0063; 0058]
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the hose barb of King in place of the hose connection of Slemker through functional equivalents since both connections appear to perform the same function of sealing. 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) 8, 11-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Slemker (6287345B1) in view of Lundt (WO95/25488) and in view of Peterson (WO8402304A1) and in view of Dillingham (2014/0039644A1).
In regard to claims 8, 11-14 Slemker teaches a prosthetic limb socket system (fig 1) configured to be able to interchangeably use multiple suspension systems (set up for an endoskeletal system in fig 3, via screws 70 and 4 hole system in fig 1; therefore capable of being used with multiple suspension systems), comprising:
a cup 12;
the suspension system 10 is selected from the group consisting of:
i.) a vacuum suspension system without release sized to substantially fit within the recess of the lower portion,
ii.) a vacuum suspension system with release sized to substantially fit within the recess of the lower portion,
iii.) a suction suspension system 10 sized to substantially fit within the recess of the lower portion (see fig 3, fits within the lower socket),
and iv.) a pin lock suspension system sized to substantially fit within the recess of the lower portion, and
wherein each of the suspension system 10 are configured to be interchangeably mountable to the lower portion (capable of due to the 4 hole design, see screws 70 in fig 1). Please note, the claim as only positively recited one of the suspension systems.
However, Slemker does not teach the socket is a conical shape, the socket material as claimed or the lower portion as claimed.
Lundt teaches a bottom end comprising a lower portion 46 (fig 3) arranged below a conical cup 44 comprising a recess portion 48. The lower portion is concave around the outer distal socket and will therefore encompass the suspension system in the distal end of the socket when combined with Slemker.
It would have been obvious to one of ordinary skill in the art at the time the invention was file to use the base of Lundt on the bottom end of the socket of Slemker because this will reinforce the distal end of the socket.
It has been held that a mere change in shape of the working parts of the invention, yielding a predictable result, requires 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 make the socket shape of the socket of Slemker conical, in order to customize the shape to a conical limb. 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 2144.04IVB
Peterson teaches a material having a first pliability at a certain temperature and a second pliability at a second temperature range wherein the second pliability is different from the first pliability (pg 10, p 2: any material which can be made sufficiently pliable to make a mold and can be hardened again on cooling)
and configured to be stretched circumferentially over a residual limb or a model of a residual limb (pg 10, p 2: to make a mold);
Peterson further teaches the first temperature range comprises a temperature in a range from about 160 F to 305 F, 225 to 290F, 250-285F. (pg 10, p 2: 225-250 degrees F); wherein the second temperature range comprises a temperature below 160 F (since the molding temperature is 225-250 F, the plastic will harden when cooled below 160F; see pg 10, p 2-3); the material comprises a thermoplastic material (pg 10, p 3: thermos-plastic); wherein the material comprises a polymeric material (a thermoplastic is a type of polymer).
It would have been obvious to one of ordinary skill in the art of rehabilitation devices and materials at the time the invention was filed to use the plastic of Peterson to manufacture the socket of Slemker because this allows direct contact molding with a barrier (pg 10, p 2-4).
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. MPEP 2144.05I
Dillingham teaches a base plate assembly 10 configured to retain the suspension systems (connects external to the socket, to the internal base plate when combined with Slemker via holes 27b and holes within the socket 82a and are therefore capable of connecting to any 4 hole endoskeletal suspension system) and to couple the prosthetic socket to a mechanical leg extension (see attaches to pylon 110 in figure 4) in an adjustable manner adjusting an alignment of the mechanical leg extension in coronal and sagittal plane orientations (see adjustments in figures 8a-c; [0013: front back, side to side and angular adjustment]).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the base plate of Dillingham in the socket of Slemker because the base plate allows for forward and backward adjustment and side to side adjustment [0098].
Claim(s) 8, 17-18, 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Slemker (6287345B1) in view of Lundt (WO95/25488) and in view of Procomp (Lower Extremity Review) and in view of Dillingham (2014/0039644A1).
In regard to claim 8, Slemker teaches a prosthetic limb socket system (fig 1) configured to be able to interchangeably use multiple suspension systems (set up for an endoskeletal system in fig 3, via screws 70 and 4 hole system in fig 1; therefore capable of being used with multiple suspension systems), comprising:
a cup 12;
the suspension system 10 is selected from the group consisting of:
i.) a vacuum suspension system without release sized to substantially fit within the recess of the lower portion,
ii.) a vacuum suspension system with release sized to substantially fit within the recess of the lower portion,
iii.) a suction suspension system 10 sized to substantially fit within the recess of the lower portion (see fig 3, fits within the lower socket),
and iv.) a pin lock suspension system sized to substantially fit within the recess of the lower portion, and
wherein each of the suspension system 10 are configured to be interchangeably mountable to the lower portion (capable of due to the 4 hole design, see screws 70 in fig 1). Please note, the claim as only positively recited one of the suspension systems.
However, Slemker does not teach the socket is a conical shape, the socket material as claimed or the lower portion as claimed.
Lundt teaches a bottom end comprising a lower portion 46 (fig 3) arranged below a conical cup 44 comprising a recess portion 48. The lower portion is concave around the outer distal socket and will therefore encompass the suspension system in the distal end of the socket when combined with Slemker.
It would have been obvious to one of ordinary skill in the art at the time the invention was file to use the base of Lundt on the bottom end of the socket of Slemker because this will reinforce the distal end of the socket.
It has been held that a mere change in shape of the working parts of the invention, yielding a predictable result, requires 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 make the socket shape of the socket of Slemker conical, in order to customize the shape to a conical limb. 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 2144.04IVB
Procomp teaches a material having a first pliability at a certain temperature (melt temperature) and a second pliability at a second temperature (below melt range) wherein the second pliability is different from the first pliability (pliable vs not pliable) and configured to stretch circumferentially over a residual limb or a model of a residual limb (stretch during vacuum forming).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the plastic of Procomp to manufacture the socket of Slemker because the material minimizes toxicity, has superior fiber flow and excellent finishing (see description).
Dillingham teaches a base plate assembly 10 configured to retain the suspension systems (connects external to the socket, to the internal base plate when combined with Slemker via holes 27b and holes within the socket 82a and are therefore capable of connecting to any 4 hole endoskeletal suspension system) and to couple the prosthetic socket to a mechanical leg extension (see attaches to pylon 110 in figure 4) in an adjustable manner adjusting an alignment of the mechanical leg extension in coronal and sagittal plane orientations (see adjustments in figures 8a-c; [0013: front back, side to side and angular adjustment]).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the base plate of Dillingham in the socket of Slemker because the base plate allows for forward and backward adjustment and side to side adjustment [0098].
In regard to claim 17, Slemker meets the claim limitations as discussed in the rejection of claim 8, but does not teach the material as claimed.
Procomp further teaches the material comprises one or more additives (discontinuous carbon fibers) configured to increase one or more of strength and modulus of the conical cup. Increasing strength is an inherent material property of carbon fiber. Further, the claim does not state increased strength or modulus compared to any reference point.
In regard to claim 18, Slemker meets the claim limitations as discussed in the rejection of claim 17, but does not teach the material as claimed.
Procomp further teaches the material comprises a carbon fiber material. (discontinuous carbon fibers, see description)
In regard to claim 21, Slemker meets the claim limitations as discussed in the rejection of claim 8, but does not teach the base plate assembly as claimed.
Dillingham further teaches wherein the base plate assembly 10 comprises alignment features including a grid system 32 having a first axis and a second axis perpendicular to the first axis for indicating position of the mechanical leg extension relative to the base plate assembly. (see figures 7a-b)
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the base plate of Dillingham in the socket of Slemker because the base plate allows for forward and backward adjustment and side to side adjustment [0098].
Claim(s) 1 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Slemker (6287345B1) in view of Dillingham (2014/0039644A1) and in view of Lundt (WO95/25488).
In regard to claims 1 and 19, Slemker teaches a prosthetic system, comprising:
a prosthetic socket (fig 1) configured to enclose at least a portion of a residual limb (within 24), the prosthetic socket (fig 1) comprising a top end comprising a cup (12; fig 9; claim 10: shaped for receiving a patient’s limb)
suspension systems 10 configured to be installed on the bottom end of the prosthetic socket (fig 1, at the bottom of 12) wherein the suspension systems 10 wherein the suspension systems are interchangeable and sized to fit substantially within the recess portion of the base, and wherein the suspension systems are selected from the group consisting of:
(i) a vacuum suspension system without release;
(ii) a vacuum suspension with a release
(iii) a suction suspension system 10 (abstract)
and (iv) a pin lock suspension system comprising a plunger pin; a bridge comprising a first leg portion having a first base plug and a second leg portion having a second base plug, wherein the first base plug and the second base plug are configured to be plugged into a base opening formed at the bottom end of the prosthetic socket for mounting the pin lock suspension system onto the bottom end of the prosthetic socket.
However, Slemker does not teach a base plate which is adjustable in the coronal and saggital directions, the base or that the socket is a conical shape or at least different four suspension systems.
Lundt teaches the prosthetic socket 44 comprising a bottom end comprising a base 46 (fig 3) including a recess portion extending from an end portion of the base to a top portion of the base (as shown in figure 3, 44 fits within 46 and therefore 46 has a recess for the socket to fit into; 46 is taught as a cup shaped adapter and a cup is hollow).
It would have been obvious to one of ordinary skill in the art at the time the invention was file to use the base of Lundt on the bottom end of the socket of Slemker because this will reinforce the distal end of the socket.
Dillingham teaches a base plate assembly 10 configured to retain each of the selected suspension systems (connects external to the socket, to the internal base plate when combined with Slemker via holes 27b and holes within the socket 82a and are therefore capable of connecting to any 4 hole endoskeletal suspension system) and to couple the prosthetic socket to a mechanical leg extension (see attaches to pylon 110 in figure 4) in an adjustable manner adjusting an alignment of the mechanical leg extension in coronal and sagittal plane orientations (see adjustments in figures 8a-c; [0013: front back, side to side and angular adjustment]);
wherein the base plate assembly 10 comprises alignment features including a grid system 32 having a first axis and a second axis perpendicular to the first axis for indicating position of the mechanical leg extension relative to the base plate assembly. (see figures 7a-b)
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the base plate of Dillingham in the socket of Slemker because the base plate allows for forward and backward adjustment and side to side adjustment [0098].
It has been held that a mere change in shape of the working parts of the invention, yielding a predictable result, requires 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 make the socket shape of the socket of Slemker conical, in order to customize the shape to a conical limb. 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 2144.04IVB
It has been held that a mere duplication of the working parts of an invention, yielding a predictable result, requires 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 have additional suspension systems (at least 4) available to use for multiple patients or incase repair is needed. Absent a teaching of criticality (new or unexpected results), this arrangement is deemed to have been known by those skilled in the art a the time the invention was filed. MPEP 2144.04IVB
In regard to claim 20, Slemker meets the claim limitations as discussed in the rejection of claim 6, but does not teach the base plate assembly as claimed.
Dillingham further teaches wherein the base plate assembly 10 comprises alignment features including a grid system 32 having a first axis and a second axis perpendicular to the first axis for indicating position of the mechanical leg extension relative to the base plate assembly. (see figures 7a-b)
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the base plate of Dillingham in the socket of Slemker because the base plate allows for forward and backward adjustment and side to side adjustment [0098].
Response to Arguments
In regard to the 112b rejection of claims 1, 6, 11-13, the amendments overcome the 112b rejection of claims 1 and 11-13. The improper Markush group in claim 6 has not been corrected and is therefore maintained.
In regard to the 112d rejection of claims 4-5, the rejection has been overcome.
In regard to the 103(a) rejection of claims 1-2, 6-7 as unpatentable over Slemker (6287345B1) in view of Dallos (2005/0267600A1) and in view of Lundt (WO95/25488), the applicant’s arguments have been fully considered. The applicant argues that Slemker discloses only a single suction suspension system and does not teach interchangeability between different suspension types. The claims do not actually require different types of suspension systems only multiple “different” suspension systems. Further, any 4-hole device will be interchangeable since endoskeletal components have standard attachments. The examiner suggests claiming the details of the systems and positively reciting the systems (using a Markush group does not require all 4 types of systems as currently written).
The applicant further argues that Lundt does not teach adjustable alignment in coronal and saggital plane orientations. Lundt clearly teaches adjustability via the dovetail mechanism in perpendicular planes plus rotation and length via the tube clamp which covers virtually all major axes in figure 1.
The applicant argues that using a change in shape to meet the limitation of a conical cup is improper because the shape is functionally significant because it affects the stretching capability of the cup. The stretching is a material property. The applicant has not shown criticality (new or unexpected results) by changing the shape of the cup. Users have different shapes of limbs and it is common and well known in the art of prosthetics to change the socket or cup shape to meet the shape of the residual limb of the user.
The applicant argues the combination of Lemker, Lundt and Dallos relies on improper hindsight but has not pointed out any particular reasoning about which motivation they believe was gleaned from the instant application instead of the prior art.
The remainder of the arguments are directed toward new claim limitations which have been addressed above.
In regard to the 103(a) rejection of claims 6-7 as unpatentable over Slemker (6287345B1) in view of Dallos (2005/0267600A1) and in view of Lundt (WO95/25488) and in view of Coppens (WO2008/116025A1), no further arguments have been submitted.
In regard to the 103(a) rejection of claim 4 as unpatentable over Slemker (6287345B1) in view of Dallos (2005/0267600A1) and in view of Lundt (WO95/25488) and further in view of Bouch (WO2014/035561A1), no further arguments have been submitted.
In regard to the 103(a) rejection of claim 5 as unpatentable over Slemker (6287345B1) in view of Dallos (2005/0267600A1) and in view of Lundt (WO95/25488) and further in view of Rush (20050240282A1) and further in view of King (2007/0055383A1), no further arguments have been submitted.
In regard to the 103(a) rejection of claims 8 and 17-18 as unpatentable over Slemker (6287345B1) in view of Dallos (2005/0267600A1) and in view of Lundt (WO95/25488) and further in view of ProComp (Lower Extremity Review), no further arguments have been submitted.
In regard to the 103(a) rejection of claims 8, 11-16 as unpatentable over Slemker (6287345B1) in view of Lundt (WO95/25488) and in view of Peterson (WO8402304A1), no further arguments have been submitted.
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 CHRISTIE BAHENA whose telephone number is (571)270-3206. The examiner can normally be reached M-F 9-3.
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/CHRISTIE BAHENA/Primary Examiner, Art Unit 3774