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 .
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) 1 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 1, the scope of “room temperature” is unclear since a room can be any temperature depending on which room. The instant disclosure does not provide any clarification or range for what room temperature comprises.
Since claims 5, 7, 10-12 depend from claim 1, these claims 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) 14, 17-20, 23-24, 30-31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Slemker (5980803) in view of Hurley (2013/0123940A1) and in view of IRIC (Prosthetics-Orthotics Thermoforming Polypropylene) and further in view of in view of Perkins (2008/0161939A1).
In regard to claim 14, Slemker teaches an outer layer, comprising:
the pre-dimensioned outer layer 12 configured to be molded to an outer circumference of the conical cup during a co-injection process (Col 1, lines 25-30: interlaying sockets; therefore inner socket will match outer socket 12 as shown in fig 1; the layers are capable of being molded during a co-injection process and interlaying in a mold and further this is a product-by-process limitation, patentable only based on the resulting structure. Since the end structure is the same, the claim limitations have been met.)
and configured to be arranged in a mold used to form the conical cup before heating the flexible pre-dimensioned outer layer such that the outer layer is in the mold in a conical configuration of the cup to be formed (the mold has not been described but outer layer 12 is fully capable of being arranged in a mold with a conical cup before heating. This is a product-by-process limitation patentable only based on the resulting end structure of the interlaying sockets. The plastic is capable of being pre-formed before using. However, only the end structure is actually claimed because this is an apparatus claim);
wherein the outer layer is flexible (heating a thermoplastic perform until it is soft and flexible; therefore the outer layer is flexible in nature at least while heated; Col 1, lines 40-45; made from a perform plastic; includes a flexible thermoplastic material Col 1, lines 40-65).
However, Slemker remains silent to the socket thickness, and that the outer layer is substantially planar or that the outer layer and conical cup are attached by co-injection or that the outer layer comprises a conical geometry.
Hurley teaches an outer layer attached to a conical cup in which the outer socket and inner cup substantially follow each other’s contours and adhered which through product-by-process results in the same end structure as co-injection [0123; fig 1].
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to adhere the outer layer and conical cup of Slemker in a complimentary manner as taught by Hurley because this will ensure an optimal and secure fit without voids [0123].
IRIC teaches a substantially planar pre-dimensioned outer layer configured to be attached to an outer circumference of a conical cup of a prosthetic socket (see figure of final making of socket, pg 11);
Wherein the substantially planar pre-dimensioned outer layer (pg 11) comprises an inside surface, an opposite outer surface, a top, a bottom separated from the top, a first side extending from the bottom to the top a first angle measured between the first side and the bottom, and second side opposite the first side extending from the bottom to the top at a second angle measured between the second side and the bottom (see figure of plastic sheet, pg 11);
Wherein the substantially pre-dimensioned outer layer comprises a thermoplastic material (polypropylene, pg 7) that is malleable after being heated to a shaping temperature (pg 7, heating temperatures).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to make the outer socket of Slemker using the plastic of IRIC through functional equivalents since both plastics are used to fabricate prosthetic sockets and it appears either plastic would work equally well. Absent a teaching of criticality (new or unexpected results), this arrangement is considered known to those skilled in the art at the time the invention was filed. MPEP 2144.06II
While the combination of Slemker in view of IRIC does not teach the socket thickness as claimed, the thickness is a result effective variable with a thicker socket being stronger with less flexibility and greater weight and a thinner socket having more flexibility but less strength and less weight. Accordingly, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to have an outer layer thickness from 0.1-1mm for a pediatric a low activity patient that needs more flexibility and decreased socket weight. Absent a teaching of criticality (new or unexpected results), the outer layer thickness in a range of of 0.1-1mm is deemed to have been known by those skilled in the art at the time the invention was filed. MPEP 2144.06II
Perkins teaches the top (proximal end) comprises a top region extending from the first side to the second side (medial to lateral) and the top region in an arch geometry (see 117 in figure 6) wherein the bottom (distal end) comprises a bottom region extending from the first side to the second side in an arch geometry (see figure 6, distal socket forms an arch to encompass the lock).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the socket brim design and distal design of Perkins in place of the socket shape of Slemker because the socket design reduces support on the patellar tendon for an individual with scar tissue in that location (abstract).
It has been held that a mere change in shape 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 make the outer layer of Slemker conical when in a mold in order to match a conical shaped limb, since the socket is custom shaped to the individual residual 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
In regard to claims 17-18, Slemker meets the claim limitations as discussed in the rejection of claim 14, but does not teach the outer layer as claimed.
IRIC further teaches the outer layer first angle is greater than 90 degrees but remains silent to the exact angle (see page 11). While IRIC does not recite the angle IRIC does teach calculating the dimensions and therefore the angle based on the size of the limb/model. (pg 11)
Accordingly, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to optimize the outer layer angle of Slemker in view of IRIC to have an outer layer first angle in the range of 93 to 97 degrees since it has been held that a mere optimization of the working parts of an invention, yielding a predictable result, requires no more than routine skill in the art. The angle is a result-effective variable with a larger angle being appropriate for a limb shape with larger condyles and a smaller limb and a smaller angle fitting over a limb model with a straighter shape. 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 2144.05IIA
In regard to claims 19-20, Slemker meets the claim limitations as discussed in the rejection of claim 14, but does not teach the outer layer details as claimed.
IRIC further teaches the outer layer second angle is greater than 90 degrees as discussed in the rejection of claim 14, but remains silent to the exact angle (see page 11). While IRIC does not recite the angle IRIC does teach calculating the dimensions and therefore the angle based on the size of the limb/model. (pg 11)
Accordingly, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to optimize the outer layer angle of Slemker in view of IRIC to have an outer layer first angle in the range of 93 to 97 degrees since it has been held that a mere optimization of the working parts of an invention, yielding a predictable result, requires no more than routine skill in the art. The angle is a result-effective variable with a larger angle being appropriate for a limb shape with larger condyles and a smaller limb and a smaller angle fitting over a limb model with a straighter shape. 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 2144.05IIA
In regard to claims 23-24, Slemker meets the claim limitations as discussed in the rejection of claim 14, but does not teach the details of the outer layer as claimed.
IRIC further teaches the substantially planar pre-dimensioned outer layer comprises an abrasion resistance surface and a scratch resistant surface. (polypropylene, pg 5; same material as the instant invention and therefore any inherent materials of that material have also been met).
In regard to claim 30, Slemker teaches an outer layer 12 for a prosthetic socket, comprising:
A flexible (heating a thermoplastic perform until it is soft and flexible; therefore the outer layer is flexible in nature at least while heated; Col 1, lines 40-45; made from a preform plastic; includes a flexible thermoplastic material Col 1, lines 40-65) outer layer 12 sized and configured to be arranged around an outer circumference of a conical cup (flexible inner liner) of the prosthetic socket (Col 1, lines 25-35: interlaying sockets) prior to heating the substantially flexible planar pre-dimensioned outer layer (This is a product-by-process limitation patentable only based on the resulting end structure of an interlaying outer layer and conical cup),
wherein the top (brim) comprises a top region extending between the first side (medial) to the second side (lateral).
However, Slemker remains silent to the socket thickness and geometry (socket brim is cut off in the figures), a plurality of holes in the outer layer and a substantially planar pre-dimensioned outer layer or the outer socket and inner cup being adhered.
While the combination of Slemker in view of IRIC does not teach the socket thickness as claimed, the thickness is a result effective variable with a thicker socket being stronger with less flexibility and greater weight and a thinner socket having more flexibility but less strength and less weight. Accordingly, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to have an outer layer thickness from 0.1-1mm for a pediatric a low activity patient that needs more flexibility and decreased socket weight. Absent a teaching of criticality (new or unexpected results), the outer layer thickness of 0.1-1mm is deemed to have been known by those skilled in the art at the time the invention was filed. MPEP 2144.06II
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the socket thickness of Coppens in the device of Slemker in view of IRIC because this is a typical socket wall thickness [00041] and a thinner socket allows for more flexibility and a lighter weight.
Perkins teaches the top (proximal end) comprises a top region extending from the first side to the second side (medial to lateral) and the top region in an arch geometry (see 117 in figure 6) wherein the bottom (distal end) comprises a bottom region extending from the first side to the second side in an arch geometry (see figure 6, distal socket forms an arch to encompass the lock).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the socket brim design and distal design of Perkins in place of the socket shape of Slemker because the socket design reduces support on the patellar tendon for an individual with scar tissue in that location (abstract).
IRIC teaches a substantially planar pre-dimensioned outer layer (page 11, see figure of plastic sheet);
wherein outer layer 12 comprises an inside surface, an opposite outside surface, a top, a bottom spaced apart from the top, a first side extending from the bottom to the top at a first angle measured between the bottom and the first side, and a second side opposite the first side extending from the bottom to the top at a second angle measured between the bottom and the second side (figure 1).
IRIC further teaches the outer layer first angle is greater than 90 degrees but remains silent to the exact angle (see page 11). While IRIC does not recite the angle IRIC does teach calculating the dimensions and therefore the angle based on the size of the limb/model.
Accordingly, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to optimize the outer layer angle of Slemker in view of IRIC to have an outer layer first angle in the range of 93 to 97 degrees since it has been held that a mere optimization of the working parts of an invention, yielding a predictable result, requires no more than routine skill in the art. The angle is a result-effective variable with a larger angle being appropriate for a limb shape with larger condyles and a smaller limb and a smaller angle fitting over a limb model with a straighter shape. 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 2144.05IIA
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to make the outer socket of Slemker using the plastic of IRIC through functional equivalents since both plastics are used to fabricate prosthetic sockets and it appears either 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
Hurley teaches an outer layer adhered to a conical cup in which the outer socket and inner cup substantially follow each other’s contours [0123; fig 1] and the socket is adhered to an outer surface of the conical cup [0123: silicone adhesive] prior to shaping or molding the conical cup (This is a product-by-process limitation, patentable only based on the resulting structure. Since the end structure of an outer layer adhered to a conical cup has been met, the limitations have been met).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to adhere the outer layer and conical cup of Slemker in a complimentary manner as taught by Hurley because this will ensure an optimal and secure fit without voids [0123].
In regard to claim 31, Slemker meets the claim limitations as discussed in the rejection of claim 26, but does not teach the outer layer as claimed.
IRIC further teaches the shaping temperature is in a range from 180 °F to 300 °F. (pg 7; 180 degrees) Further the polypropylene material of IRIC is the same material listed in the instant invention and any inherent properties such as the shaping temperature are also then met by the material.
Claim 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Slemker (5980803) in view of Hurley (2013/0123940A1) in view of IRIC (Prosthetics-Orthotics Thermoforming Polypropylene) and in view of in view of Perkins (2008/0161939A1) and further in view of Clausen (2006/0161267A1).
In regard to claim 25, Slemker meets the claim limitations as discussed in the rejection of claim 14, but does not teach the substantially planar inside surface comprises a heat activated adhesive.
As discussed in the rejection of claim 14, IRIC teaches a substantially planar outer layer. (pg 11)
Clausen further teaches the adhesive layer [0033: epoxy resin] comprises a heat activated adhesive [0035: construct is cured to a temperature between 107-150 degrees C].
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the film assembly of Clausen on the inside surface socket of Slemker because it allows a design to be applied with reduced wear and tear [0003] for marketing purposes.
Claim(s) 26-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Slemker (5980803) in view of IRIC (Prosthetics-Orthotics Thermoforming Polypropylene), in view of Hurley (2013/0123940A1), and in view of Perkins (2008/0161939A1) and further in view of Vo (2011/0320010A1).
In regard to claim 26, Slemker meets the claim limitations as discussed in the rejection of claim 14, but does not teach the outer layer comprises a plurality of holes.
Vo teaches the outer layer (socket) comprises a plurality (two or more) of holes 18).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the holes of Vo in the outer layer of Slemker because the holes provide air flow through the socket as well as traction [0043].
In regard to claims 27-28, Slemker meets the claim limitations as discussed in the rejection of claim 14, but does not teach the plurality of holes.
Vo teaches the outer layer (socket) comprises a plurality (two or more) of holes 18).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the holes of Vo in the outer layer of Slemker because the holes provide air flow through the socket as well as traction [0043].
While the combination of Slemker in view of Vo remains silent to the dimensions of the holes or grid patterns, it has been held that a mere optimization of a result-effective variable, requires no more than routine skill in the art. Larger holes with decreased dimensions between them will create greater ventilation with less support while smaller holes with a greater distance between will create less ventilation but more support. Accordingly, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Slemker in view of Vo’s holes to have the plurality of holes are arranged in a grid pattern of about 0.2 inches, wherein each of the plurality of holes comprise a diameter in a range from 0.001 inches to 0.004 inches. 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 2144.05IIA
Claim(s) 46-47 is/are rejected under 35 U.S.C. 103 as being unpatentable over Slemker (5980803) in view of Hurley (2013/0123940A1) and in view of IRIC (Prosthetics-Orthotics Thermoforming Polypropylene) and further in view of in view of Perkins (2008/0161939A1) and further in view of Clausen (2006/0161267A1).
In regard to claim 46, Slemker meets the claim limitations as discussed in the rejection of claim 14, but does not teach the substantially planar pre-dimensioned outer layer further comprises a feature selected from the group consisting of a graphic pattern, a logo and a color.
Clausen teaches the substantially flexible planar pre- dimensioned outer layer further comprises a feature selected from the group consisting of a graphic pattern, a logo, and a color. (see 7, figure 1: Ossur logo; 0027: first film can be colored)
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the film assembly of Clausen on the outer socket of Slemker because it allows a design to be applied with reduced wear and tear [0003].
In regard to claim 47, Slemker meets the claim limitations as discussed in the rejection of claim 30, but does not teach the inside surface comprises a heat activated adhesive material.
Clausen teaches the inside surface comprises a heat activated adhesive material. [0033: each layer of shapable material 40 has an epoxy resin on at least one surface of the layer; see fig 6A].
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to apply the heat activated adhesive material of Clausen to the inside surface of the outer layer of Slemker because this allows a logo or graphic pattern to be applied with reduced wear and tear [0003].
Allowable Subject Matter
Claims 1, 5, 7, 10-12 do not currently have art applied but have rejections under 112a and b as noted above. If the scope of the claims is modified this may change the ability to apply a prior art rejection.
Response to Arguments
In regard to the 112a rejection of claim 1, the applicant’s arguments have been fully considered. The claim was rejected for failing to provide support for “the outer layer is flexible at room temperature”. The applicant argues that the examiner must provide evidence the limitation is not supported. By pointing out the limitation does not appear to be supported anywhere in the instant disclosure, sufficient evidence has been provided. MPEP 2163.04I “There does not appear to be a written description of the claim limitation___” may be sufficient where the claim is a new or amended claim, the support for the limitation is not apparent and the applicant has not pointed out where the limitation is supported.”
In the response to arguments, the applicant asserts that [0129, 0130, 0135, 0145, 0150, 0154, 0155] and figures 17A-B, 18B and 19B support this limitation. But has not pointed out specific limitations
[00129] of the instant disclosure discusses the outer layer being malleable after being heated to a shaping temperature and in fact states the outer layer is non-malleable upon cooling from the shaping temperature, actually teaching against the outer layer being flexible at room temperature.
[00130] of the instant disclosure states that the outer layer can be less malleable than the conical cup at the shaping temperature which is heated to above room temperature.
[00145] states that the outer layer is laser cut and does not discuss the flexibility.
[00150] states that the outer layer has holes and does not discuss flexibility.
[00154] states the outer layer is arranged over the conical cup but does not discuss the flexibility.
[00155] states that the outer layer is head from 160-350 degrees F. This is well above room temperature.
Figures 17A-B, 18B and 19B show the plastic being flat and then formed into a socket but the figures do not show any particular temperature or support the outer layer being flexible specifically at room temperature.
The applicant points out heating the outer layer to place it over a conical cup at [0154-0155]. One of ordinary skill in the art would recognize that the temperature of the outer layer with a heat gun is not room temperature and those paragraphs in fact point out the outer layer is head to 160-350 degrees F. One of ordinary skill in the art would recognize that is not room temperature in any definition since the hottest weather ever recorded on earth is only 134 degrees F.
Accordingly, no support has been provided for the outer layer being flexible at room temperature. Accordingly, the 112a written description rejection is maintained.
In regard to the 112b rejection of claim 1 for reciting “room temperature”, the applicant has cited room temperature is defined by the American Heritage Dictionary as 68 to 72 degrees F. However, various different dictionaries all give different definitions of the range of room temperature. For example, the Merriam Webster dictionary defines room temperature as 59-77 degrees F and the Collins dictionary defines room temperature as 68-77 degrees F. Accordingly, the use of the term room temperature, without a definition in the specification is indefinite. To choose a particular, inconsistent definition would be putting new, unsupported limitations into the disclosure/claims.
In regard to the 103(a) rejection of claims 14, 17-20, 23-24 and 30-31 as unpatentable over Slemker (5980803) in view of Hurley (20130123940A1) and in view of IRIC (Prosthetics-Orthotics Thermoforming Polypropylene) and further in view of Perkins (2008/0161939A1), the applicant’s arguments have been fully considered but are all directed toward new claim limitations which have been addressed above. The amended claim limitations are phrased as method steps but the claims are apparatus claims. Accordingly, with product by process limitations, only the end structure is patentable. The examiner suggests claiming limitations based on the desired end structure rather than in this manner.
In regard to the 103(a) rejection of claim 25 as unpatentable over Slemker (5980803) in view of Hurley (20130123940A1) and in view of IRIC (Prosthetics-Orthotics Thermoforming Polypropylene) and further in view of Perkins (2008/0161939A1) and further in view of Clausen (2006/0161267A1), no further arguments have been submitted.
In regard to the 103(a) rejection of claims 26-28 as unpatentable over Slemker (5980803) in view of Hurley (20130123940A1) and in view of IRIC (Prosthetics-Orthotics Thermoforming Polypropylene) and further in view of Perkins (2008/0161939A1) and further in view of Vo (2011/0320010A1), no further arguments have been submitted.
In regard to the 103(a) rejection of claims 46-47 as unpatentable over Slemker (5980803) in view of Hurley (20130123940A1) and in view of IRIC (Prosthetics-Orthotics Thermoforming Polypropylene) and further in view of Perkins (2008/0161939A1) and further in view of Vo (2011/0320010A1) and further in view of Clausen (2006/0161267A1), 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