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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 6/9/2026 has been entered.
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. (For example, “room temperature” in an igloo is not the same as “room temperature” in a green house. Even room temperature in various homes will be different.) The instant disclosure does not provide any clarification or range for what room temperature comprises. Flexibility at “room temperature” will describe a different material depending what room temperature comprises.
Since claims 5, 7, 10-12 depend from claim 1, these claims are also rejected under 112b.
Claim Objections
Claim(s) 1 is/are objected to because of the following informalities:
In regard to claim 1, the claim recites “the mold is configured to be make a conical cup of the prosthetic socket”. The claim should read “the mold is configured to make a conical cup of the prosthetic socket” for proper grammar.
Appropriate correction is required.
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, 7, 10-12 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 Clausen (2006/0161267A1).
In regard to claim 1, Slemker teaches an outer layer 12 for a prosthetic socket, the outer layer comprising:
an outer layer 12 is configured to be arranged inside a mold and circumferentially cover a surface of the mold, the mold having a conical geometry where the mold configured to be make a conical cup of the prosthetic socket; (Col 1, lines 25-35; this is product by process, patentable only based on the resulting structure of a conical shape; fig 3; Col 6, lines 17-28; the conical mold is not actually required or positively recited and when plastic is heated it is able to be placed in any shaped mold);
wherein the outer layer is flexible in nature at room temperature. (Col 1, lines 55-65: polypropylene; According to the applicant’s arguments polypropylene is inherently flexible at room temperature. Since the thermoplastic of Slemker is also polypropylene, the same material, any inherent material properties have also been met).
However, Slemker remains silent to the socket thickness, the shape of the outer socket before being molded, or the adhesive layer.
IRIC teaches the outer layer comprises a thermoplastic material (polypropylene, pg 4) configured to be malleable at a shaping temperature in a range from 180-300 degrees F (page 7: 175-180 degrees; will be malleable at higher temperatures than the oven as well) wherein the outer layer having a substantially planar dimension in a flat sheet type geometry (page 11, see figure with PP sheet dimensions) has a first side, a second side separated from the first side, a top, and bottom separated from the top (see PP sheet dimensions figure) and a thickness wherein the first side extends from the bottom at an angle greater than 90 degrees (see PP sheet dimensions figure, the angle is greater than 90 degrees);
Wherein the outer layer thermoplastic material (polypropylene is less malleable than a material of the conical cup at the shaping temperature; the conical cup of Slemker is silicone Col 1, lines 25-35 and therefore the polypropylene is less malleable). Polypropylene and silicone are listed materials of the instant application and the malleability at the shaping temperature is an inherent property. Since the same materials are used, any inherent property limitations have been met as well;
wherein the outer layer 12 has a higher abrasion resistance and scratch resistance as compared to an outer surface of the conical cup of the prosthetic socket at room temperature. The abrasion and scratch resistance is an inherent material property. The outer socket is polypropylene which is harder than the inner socket material of silicone and will therefore also have a higher abrasion and scratch resistance. Since the same materials are used as listed in the instant invention, any inherent property limitations have been met as well.
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 deemed to have been known by 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 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.
Clausen 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.
In regard to claim 5, Slemker meets the claim limitations as discussed in the rejection of claim 1, and further teaches the conical cup is thermoplastic or silicone (Col 1, lines 25-30) and the socket is polypropylene (Col 1, lines 55-65).
Further, IRIC teaches the outer layer is polypropylene as discussed in the rejection of claim 1. (pg 4)
Since the materials of the inner cup and outer layer are the same as those listed in the instant invention, any inherent properties such as the outer layer being substantially more resistance to being worn away by rubbing or friction than the conical cup have also been met.
In regard to claim 7, Slemker in view of IRIC meets the claim limitations as discussed in the rejection of claim 1, but remains silent to the thickness of the outer layer.
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. 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 have the thickness is in the range of .5mm to 1mm since the thickness is a result-effective variable with a thicker socket being stronger and a thinner socket having more flexibility. A thinner socket would be appropriate for a pediatric patient for example. Absent a teaching of criticality (new or unexpected results), the thickness of .5 to 1mm is deemed to have been known by those skilled in the art at the time the invention was filed. MPEP 2144.05II
In regard to claims 10-12, Slemker meets the claim limitations as discussed in the rejection of claim 1, but does not teach the outer layer comprises a design associated with 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].
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 12, 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.
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 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).
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);
and the outer socket is arranged inside a mold prior to heating the outer layer such that the outer layer assumes a conical configuration within the mold before the conical cup is formed thereover. This is a product-by-process limitation, patentable only based on the resulting structure of an inner and outer layer overlaying each other as shown in figure 5 and a conical shape (Col 6, lines 15-28; fig 5: distal end can require a bowl or dome shape).
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.
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
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
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).
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].
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].
Response to Arguments
The applicant has addressed the previous 112a rejection, the applicant has submitted a declaration stating that the instant specification provides support that the outer layer is flexible at room temperature. The applicant argues that [0129] of the instant disclosure stating that the outer layer is non-malleable upon cooling refers to a different property that flexibility. While this distinction is accepted, this does not provide support under 112a specifically.
The applicant argues that thin thermoplastic sheets, including polypropylene sheets with a thickness of 0.1mm to 1mm are inherently flexible at room temperature because this is a material property of polypropylene. While the examiner does not disagree with this statement, the claim does not recite polypropylene and only a generic thermoplastic. Not all thermoplastics are flexible at room temperature in this thickness range. However, for purposes of 112a, this reasoning that the flexibility is an inherent material property is accepted for support purposes. However, based on this argument, the prior art applies to the previously rejected claims as noted above.
In regard to the 112b rejection of claim 1 for failing to define the scope of room temperature, the applicant’s arguments have been fully considered. The applicant submitted a declaration of how a POSITA understand the claim language and states room temperature is 65-77 degrees F. The applicant states that the scope of room temperature is not critical to the claims. Since the language is required by the claims, the temperature is critical. The applicant states that all the dictionary definitions of room temperature recited by the examiner fall within the applicant’s disclosed range of 65-77F. However, this is not true as 59-77 is outside of this range. This rejection is maintained.
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. The applicant argues that the examiner improperly relies on product-by-process reasoning because the claims contain specific geometry and thickness. Product by process reasoning was not used to teach these specific features. The applicant further argues that the manufacturing steps of Slemker occur in a different order. The order of the manufacturing steps in an apparatus claim is product by process unless the applicant can show that a different final structure results from the reversal of steps. The remainder of the arguments are directed towards new limitations which have been addressed above.
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 presented.
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 presented.
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 Clausen (2006/0161267A1), no further arguments have been presented.
Claims 1, 5, 7 and 10-12 are rejected under 112 but do not currently have art rejections applied.
The affidavit submitted 6/9/2026 has been fully considered. The affidavit states that room temperature is a term of the art referring to approximately 65-77 degrees F and states the exact temperature is not critical but the distinction from the shaping temperature is. In this case, the examiner suggests renaming the temperature from the terminology of room temperature based on this argument. The claims recite a very generic thermoplastic, claiming properties of the plastic rather than claiming the material itself. It is suggested to just claim the material structure and materials themselves. The affidavit states that different dictionaries defining room temperature differently do not render the term indefinite. The examiner respectfully disagrees as depending on the room temperature the claim limitations how they are currently written may refer to a different material since the exact material is not recited.
Regarding the 112a rejection, the rejection has been withdrawn as noted above based on the argument that the flexibility itself is an inherent material property of polypropylene which is supported by the instant disclosure and based on the distinction between flexibility and malleability pointed out.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Barrett can be reached at 571-272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTIE BAHENA/Primary Examiner, Art Unit 3774
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