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 Objections
Claim 13 is objected to because of the following informalities:
In regard to claim 13, “seven pairs of positioning holes” should be “the positioning holes comprise seven pairs of the positioning holes” for consistent antecedent basis with claim 1 from which claim 13 depends. “Two pairs of fastener holes” should be “the fastener holes comprise two pairs of the fastener holes” for consistent antecedent basis with claim 1. “Each of the pairs” should also refer to whether the pairs are positioning or fastening holes for clarity throughout the claim.
Appropriate correction is required.
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) 15, 18 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 15, the claim recites “a circumference from about 10" to about 20" ”. The recitation of about in combination with a range renders the scope of the range in definition. The instant disclosure does not provide any further evidence regarding the scope of the term “about”.
In regard to claim 18, “the positioning web” lacks proper antecedent basis. It appears the applicant may have meant claim 18 to depend from claims 2 or 3 rather than claim 16 (which depends from claim 1).
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, 5, 8, 10, 12-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bache (2016/0331562A1) in view of Cespedes (2016/0058584A1) and in view of Bache2 (2012/0101597A1).
In regard to claim 1, Bache teaches a single socket adjustable prosthetic system (fig 39) comprising:
a. a first shell 1108 with an extended surface configured to fit against a first side of an amputee's limb, the surface terminating at a base 1124, the base 1124 configured to extend under the amputee's limb (fig 39) and the base 1124 having a limb facing surface (proximal surface) and a bottom surface (distal surface);
b. a second shell 1112 with an extended surface configured to fit against a second side of the amputee's limb;
c. an articulated hinge 1130;
a first member 1126;
and e. the articulated hinge 130 connected at the first member 1108 to the base (distal end) of the first shell 1108 and to the second shell 1112 forms a space between the first shell and the second shell 1114, the space to be varied to hold, and accommodate size, swelling, and shrinking of the amputee's limb. (see arrows fig 39).
However, Bache does not teach the details of the first member or a middle member and a second member.
Bache2 teaches the articulated hinge having a middle member (distal most 136), and a second member (middle 136),
The second member (middle 136) hingedly attached at a second end (proximal end) of the middle member (lower 136, fig 9; see arrows indicating hinges);
the second member (middle 136) of the articulated hinge attached to the second shell (indirectly attached to the strut above 136, 114 via hinges indicated by the arrows in figure 9)
with the middle member (lower 136) hingedly attached to the first member (hingedly attached-see arrows to a first member 118 as shown in figure 9; will hingedly attach to the second plate when combined with Bache in view of Bache2 based on the location and the second plate being substituted for 126 of Bache).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to add the middle and second member of Bache2 to the hinge system of Bache (applying the additional members proximal to hinge 1130) in order to increase the adjustability and customization of the socket to the user. [0007; 0085].
Cespedes teaches the first member (figure 3M-40) comprising a first plate 60 connected to a second plate 41 at an angle to each other (this could be at any angle),
d. the first plate 60 further having fastening holes (see holes that screws fit through) configured to align with positioning holes (slots within 80, fig 4A) in the base (see figure 4A, aligns with slots within base 80) to adjust the relative anterior/posterior position of the first plate 60 and the base prior to connection (see figure 4A; [0104: slidably host strut connectors]),
with the first plate 60 removably connected to the base (see figure 3M; 4A, connected via screws slots in base 80; therefore removably connected)
the fastening holes and positioning holes configured to accommodate removable fasteners (see screws in figure 3M, 4A).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the first member and base of Cespedes in place of the first member and base of Bache because this allows radial adjustment of the struts [0104].
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In regard to claim 5, Bache meets the claim limitations as discussed in the rejection of claim 1 and further teaches the first shell 1108 comprises a rigid, load bearing material [0215: plastic or other material that can resist deformation; carbon fiber] and the second shell 1112 comprises a pliable and formable material [0025: plastic is formable and pliable when heated; 0080: parts of the struts can be a compliant material].
In regard to claim 8, Bache meets the claim limitations as discussed in the rejection of claim 1 and further teaches the amputee has had a trans-tibial amputation and the first side of the amputee's limb is the front of the limb and the second side of the amputee's limb is the rear of the limb; [0064: it will be appreciated that the system may be adapted to a variety of different types of amputation for leg or arm use; therefore capable of being used for a transtibial amputation] (This claim language is interpreted as best understood to further limit limitations claim 1 regarding “configured to fit against a first side, second side of an amputee’s limb” limitations rather than positively reciting the limb. The examiner suggests clarifying this claim language.)
the second shell 1112 has an upper portion such that when the single socket adjustable prosthetic system is attached to the amputee's limb the amputee is prevented from bending of the knee (if the socket as shown in 38 was attached to a transtibial limb, due to the contour, the amputee would be unable to bend the limb since there is no popliteal cutout);
the first shell 1108 has an upper portion that covers and protects the knee (capable of when attached to a transtibial limb, depending on the limb length);
and a trim line can be cut (the upper trimline is capable of being cut given the right tools due to the material being plastic or carbon [0125]) that removes portions of the upper portion of the second shell and can remove portions of the upper portion of the first shell, to allow the amputee to flex the knee when the single socket is attached to the amputee's leg. The trimline is capable of being cut to lower the rear socket for use with a transtibial amputee as noted above.
In regard to claim 10, Bache meets the claim limitations as discussed in the rejection of claim 1, but does not teach the removable fasteners as claimed.
Cespedes further teaches the removable fasteners have threading. (see screws in figure 3M; 1E; [0227: thread into bolt holes; 0131: O-bolts, these are threaded by definition]
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the first member and base of Cespedes as well as the fasteners in place of the first member and base of Bache because this allows radial adjustment of the struts [0104].
In regard to claim 12, Bache meets the claim limitations as discussed in the rejection of claim 1 but does not teach the hinge includes a first, second and middle member as claimed.
Bache further teaches the first member 126 is attached to the limb facing (proximal) surface of the base 1124. When the first member of Cespedes is substituted for the first member of Bache as discussed above, Cespedes also teaches the first member of the articulated hinge is attached to the limb facing surface of the base (proximal face). (figure 4A-B)
Bache2 further teaches the second member (middle 136) of the articulated hinge is attached to a limb facing surface (inner surface) of the second shell (strut; will be attached to the second shell when applied to Bache). At least a portion of 136 extends inward of the strut itself as shown in figure 9) [0094: placement adjacent a residual limb] (also see for example 170 in figure 17, the hinged segment surrounds the interior segment)
In regard to claim 13, Bache meets the claim limitations as discussed in the rejection of claim 1, but does not teach the first plate as claimed.
Cespedes further teaches fastener holes (see holes within 60, figure 3C) are positioned between an anterior and a posterior end of the first plate and each of the pairs comprise a first fastener hole positioned towards a medial side of the first plate and a second fastener hole positioned towards a lateral side of the base (fig 3B);
the two pairs of fastener holes configured for alignment with a first pair of positioning holes and a second pair of positioning holes (positioning holes are within the base). The holes are capable of being aligned with the holes in the base as in about the same circumference. The claim language does not require the holes be aligned for the same fastener to fit through both.
However, the combination of Bache in view of Cespedes does not teach two pairs of positioning holes.
However, it has been held the 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 duplicate the holes in the first plate of Bache in view of Cespedes to have at least two pairs of holes for additional security and alternate fastening arrangements. MPEP 2144.04VIB
Bache2 two teaches pairs of positioning holes are positioned between an anterior and a posterior end of the base (see figure 1D),
and each of the pairs comprise a first positioning hole positioned towards a medial side of the base and a second positioning hole positioned towards a lateral side of the base (opposing pairs of holes as shown in figure 2B on opposite sides).
However, the combination of Bache in view of Bache2 does not teach seven pairs of positioning holes.
However, it has been held the 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 duplicate the holes in the base of Bache in view of Bache2 to have seven pairs of holes for additional adjustability, security and to allow additional struts to be added to the socket. MPEP 2144.04VIB
In regard to claim 14, Bache meets the claim limitations as discussed in the rejection of claim 1, but does not teach the articulated hinge further comprises a stabilizer cap connected to a base facing side of the second plate and the middle member or the second plate or middle member.
Cespedes further teaches the articulated hinge further comprises a stabilizer cap 28E connected to a base facing side (distal side) of the second plate (see figure 6B).
While the combination of Bache in view of Cespedes does not teach the middle member, Bache2 teaches the middle member as discussed in the rejection of claim 1.
The middle member attaches to the strut and therefore when applied to the strut of Bache, the middle member will be indirectly attached to the base and therefore stabilizer cap of Cespedes which attach to the strut and base at 1126 of Bache.
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the first member of Cespedes (and the associated slots in the base) in place of the first member of Bache because this allows radial adjustment of the struts [0104] and the stabilizer cap 26-E provides additional support and strength. [0130: metal cladding]
In regard to claim 15, Bache meets the claim limitations as discussed in the rejection of claim 1, and further teaches the space varied to hold and accommodate size, swelling and shrinking of the amputee's limb (inner socket, figure 38) is configured to accommodate a limb.
However, Bache remains silent to the circumference of the socket.
It has been held that a mere change in size 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 the space having a circumference value in between about 10" to about 20" in order to change the dimensions of the socket for the particular user. It appears this circumference would work equally well has a smaller or larger circumference socket depending on the size of the user. 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 2144.04IVA
In regard to claim 16, Bache meets the claim limitations as discussed in the rejection of claim 1, but remains silent to the socket length. The socket shown in figure 38 can be used on either a right or left side residuum due to its symmetrical design. The sockets are capable of accepting a residual limb length longer or shorter than the socket.
It has been held that a mere change in size 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 the space having a length from 5 to 7 inches or 7 to 9 inches in order to change the length of the socket for the particular user. It appears this length would work equally well than a longer or shorter socket depending on the residual limb length of the user. 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 2144.04IVA
In regard to claim 17, Bache meets the claim limitations as discussed in the rejection of claim 16, but does not teach the stabilizer cap.
Cespedes further teaches the articulated hinge with the stabilizer cap 26-E is positioned on the baseplate (on baseplate 80 as shown in figures 4A-4B; further substituted for 1126 of Bache which is on baseplate 1124).
However, the combination of Bache in view of Cespedes remains silent to the anterior posterior length (of adjustment).
It has been held that a mere change in size 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 modify the anterior posterior adjustment length of Bache in view of Cespedes to be a value between 5" to 6.5" to meet the needs of the particular user. 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 2144.04IVA
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bache (2016/0331562A1) in view of Cespedes (2016/0058584A1) and in view of Bache2 (2012/0101597A1) and further in view of Benson (2006/0079965A1).
In regard to claim 4, Bache meets the claim limitations as discussed in the rejection of claim 1, and further teaches
a shaft connected at a top end to the bottom surface of the base and the shaft projecting from the base to a bottom end [0065: base connector adapted to connect to pylon];
and a prosthetic foot [0065: adapted to connect to artificial foot]
and wherein the single socket adjustable prosthetic system when attached to the limb of the amputee can be used to stand and for mobility (capable of by supporting the residual limb within the socket as shown in figure 38; [0065]).
However, Bache does not specifically teach that the foot is attached to the end of the shaft, although how a foot attaches to a prosthesis is well known in the art.
Benson teaches attaching the prosthetic foot 60 to the bottom end of the shaft 50 (figure 2).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to use the foot of Bache on the bottom end of the shaft of Bache as in the configuration taught by Benson because this allows the prosthetic to mimic a human leg and operate as intended, as well as providing additional length by using the pylon between the socket and foot depending on the residual limb length.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bache (2016/0331562A1) in view of Cespedes (2016/0058584A1) and in view of Bache2 (2012/0101597A1) and further in view of Asgeirsson (2008/0004715A1).
In regard to claim 6, Bache meets the claim limitations as discussed in the rejection of claim 5 and further teaches the first shell material 1108 is a carbon fiber [0215].
However, Bache does not specifically teach the carbon is use with epoxy resin.
Asgeirsson teaches making a socket using carbon and epoxy resin. [0083]
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the epoxy of Asgeirsson in order to manufacture the carbon socket of Bache because the epoxy acts as a binder and allows the carbon to cure in the desired form.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bache (2016/0331562A1) in view of Cespedes (2016/0058584A1) and in view of Bache2 (2012/0101597A1) and further in view of O’Brien (2018/0110633A1).
In regard to claim 7, Bache meets the claim limitations as discussed in the rejection of claim 5 but does not teach the second shell is polyethylene.
O’Brien teaches making part of a prosthetic socket (the second shell material) from polyethylene. [0006]
It would have been obvious to one of ordinary skill in the art at the time the invention was made to make the lateral wall of Bache of polyethylene as taught by O’Brien because this prevents impingement on the tissue when the socket is tightened [0006] and allows for comfort and adjustability.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bache (2016/0331562A1) in view of Cespedes (2016/0058584A1) and in view of Bache2 (2012/0101597A1) and further in view of Hurley (2013/0123940A1).
In regard to claim 9, Bache meets the claim limitations as discussed in the rejection of claim 8, and further teaches the socket may be adapted to a variety of different types of amputations for the leg or arm [0064] but does not teach a SCSP, SC or PTB trimline.
Hurley teaches the trim line cut of the upper portion of the second shell and the first shell is selected from the group consisting of: a supra condylar supra patellar (SCSP) trim line, a supra condylar (SC) trim line, and a patellar tendon bearing (PTB) trim line [0209: interface pad specially designed for the patellar tendon area; see fig 24].
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the trimline of Hurley in the socket of Bache in order to adapted the socket for a transtibial amputee and to offload weight bearing onto pressure tolerant (patellar tendon) areas of the limb.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bache (2016/0331562A1) in view of Cespedes (2016/0058584A1) and in view of Bache2 (2012/0101597A1) and further in view of Molino (2004/0083007A1).
In regard to claim 18, Bache meets the claim limitations as discussed in the rejection of claim 16, but does not teach a positioning wedge positioned on the baseplate or the anterior posterior length.
Molino teaches the positioning wedge 90 is positioned on the baseplate (plate underneath attached to 46 in figure 16C).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the positioning wedge of Molino between the baseplate and first member of Bache in view of Cespedes because this allows changes in the socket angle when adjustments are necessary [0057].
While Bache in view of Bache2 does not teach the anterior posterior adjustment length, it has been held that a mere change in size 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 use an anterior posterior length of a value between 3.8" to 5.3" in order to customize the socket/plate size to the individual user. 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 2144.04IVA
Allowable Subject Matter
Claim(s) 2-3, 11 is/are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
In regard to claim 2, Bache (2016/0331562A1) in view of Cespedes (2016/0058584A1) and in view of Bache2 (2012/0101597A1) meets all of the claim limitations except “wherein the base distal portion of the first shell has a rim around a rear portion of the base opposite the connection of the extended surfaces connection to the base;
the hinged attachment of the first member to the middle member is positioned at the base of the rim when the first member is connected to the interior of the base;
and the space between the middle member and the rim is adjusted by a wedge connected to the middle member and the first member” in combination with the other claim limitations.
While Molino (2004/0083007A1) teaches using a wedge to adjust a socket position, Molino does not teach adjusting the space between the middle member and rim.
In regard to claim 3, Bache (2016/0331562A1) in view of Cespedes (2016/0058584A1) and in view of Bache2 (2012/0101597A1) meets all of the claim limitations except “the base of the first shell has a rim around a rear portion of the base opposite the connection of the extended surfaces connection to the base;
the hinged attachment of the first member to the middle member is positioned at the base of the rim when the first member is connected to the interior of the base;
and the space between the middle member and the rim is adjusted by at least one wedge inserted between the middle plate and the rim” in combination with the other claim limitations.
While Molino (2004/0083007A1) teaches using a wedge to adjust a socket position, Molino does not teach adjusting the space between the middle member and rim.
Conclusion
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