DETAILED ACTION
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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim Objections
Claims 4, 9, 12, 16, and 18 are objected to because of the following informalities:
Regarding claim 4, the limitation “the exterior fabric layer” is recited in line 1. The limitation should read “the external fabric layer”.
Regarding claim 9, the limitation “the knitted fabric” is recited in line 7. The limitation should read “the stitched fabric”.
Regarding claim 9, the limitation “the knitted fabric” is recited in line 8. The limitation should read “the stitched fabric”.
Regarding claim 12, the limitation “the knitted fabric” is recited in lines 1-2. The limitation should read “the stitched fabric”.
Regarding claim 16, the limitation “the knitted fabric” is recited in line 7. The limitation should read “the fabric”.
Regarding claim 16, the limitation “the knitted fabric” is recited in line 8. The limitation should read “the fabric”.
Regarding claim 18, the limitation “the knitted fabric” is recited in lines 1-2. The limitation should read “the fabric”.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2, 7-10, 14-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schaffer et al. (US 2005/0149202).
Regarding claim 1, Schaffer discloses a fabric reinforced prosthetic liner (100) comprising: the prosthetic liner having an open proximal end (112), closed distal end (114), and sidewalls (side panel 160, 170, See Fig 3) wherein the prosthetic liner (100) has an inner thermoplastic layer (120) comprising a moldable material (see [0052] disclosing use of thermoplastic cushioning material) and an external fabric layer (118) comprising a knitted fabric having a fabric thickness (see par. [0047] disclosing that the fabric used is knitted), the inner thermoplastic layer (120) further comprising an interior fabric (116) impregnated with the moldable material (see [0035] disclosing that the interior is impregnated with a cushioning material); wherein the interior fabric (116) and the knitted fabric do not exhibit shearing when stretched (see par. [0046] disclosing that the interior and exterior fabrics have elasticity that permits the liner to stretch) and the knitted fabric does not contain any moldable material through the fabric thickness (see par. [0047] disclosing that the cushioning material only migrates through the fabric of the interior surface and that the exterior surface is free from cushioning material).
Regarding claim 2, discloses the fabric reinforced prosthetic liner (100) of Claim 1 wherein the knitted fabric is polyester (see par. [0047] stating that the fabric is a polyester knit fiber).
Regarding claim 7, Schaffer discloses the fabric reinforced prosthetic liner (100) of Claim 1 wherein the moldable material is silicone (see par. [0052] disclosing the cushioning material can be silicone).
Regarding claim 8, Schaffer discloses the fabric reinforced prosthetic liner (100) of Claim 1 wherein the moldable material is a styrene-based thermoplastic elastomer (see par. [0055] disclosing the cushioning material can be styrene-ethylene/butylene-styrene block copolymers or be styrene-ethylene/propylene-styrene block copolymers).
Regarding claim 9, A fabric reinforced prosthetic liner (100) comprising: the prosthetic liner (100) having an open proximal end (112), closed distal end (114), and sidewalls (side panel 160, 170, see Fig. 3) wherein the sidewalls (160, 170) have an inner thermoplastic layer (120) comprising a moldable material (see [0052] disclosing use of thermoplastic cushioning material) and an external fabric layer (118) comprising a stitched fabric having a fabric thickness (see par. [0046] disclosing that the fabric can be non-woven), the inner thermoplastic layer (120) further comprising an interior fabric (116) impregnated with the moldable material (see [0035] disclosing that the interior is impregnated with a cushioning material); wherein the interior fabric (116) and the stitched fabric do not exhibit shearing when stretched ((see par. [0046] disclosing that the interior and exterior fabrics have elasticity that permits the liner to stretch) and the stitched fabric does not contain any thermoplastic material through the fabric thickness (see par. [0047] disclosing that the cushioning material only migrates through the fabric of the interior surface and that the exterior surface is free from cushioning material).
Regarding claim 10, The fabric reinforced prosthetic liner of Claim 9 wherein the stitched fabric is polyester (see par. [0047] stating that the fabric is polyester).
Regarding claim 14, The fabric reinforced prosthetic liner (100) of Claim 9 wherein the moldable material is silicone (see par. [0052] disclosing the cushioning material can be silicone).
Regarding claim 15, The fabric reinforced prosthetic liner (100) of Claim 9 wherein the moldable material is a styrene-based thermoplastic elastomer (see par. [0055] disclosing the cushioning material can be styrene-ethylene/butylene-styrene block copolymers or be styrene-ethylene/propylene-styrene block copolymers).
Regarding claim 16, Schaffer discloses a fabric reinforced prosthetic liner (100) comprising: the prosthetic liner (100) having an open proximal end (112), closed distal end (114), and sidewalls (side panels 160, 170, see Fig 3) wherein the sidewalls (160, 170) have an inner thermoplastic layer (120) comprising a moldable material (see [0052] disclosing use of thermoplastic cushioning material) and an external fabric layer (118) comprising a fabric having a fabric thickness (see par. [0047] disclosing the use of a fabric), the inner thermoplastic layer (120) further comprising an interior spacer fabric (116) (see par. [0047] disclosing use of waffle-like texture fabric forming interstices across the surface) impregnated with the moldable material (see [0035] disclosing that the interior is impregnated with a cushioning material); wherein the interior fabric (116) and the fabric do not exhibit shearing when stretched (see par. [0046] disclosing that the interior and exterior fabrics have elasticity that permits the liner to stretch) and the knitted fabric does not contain any moldable material through the fabric thickness (see par. [0047] disclosing that the cushioning material only migrates through the fabric of the interior surface and that the exterior surface is free from cushioning material).
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.
Claims 3, 11, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Schaffer et al. (US 2005/0149202) in view of Janusson et al (US 2004/0059432). Regarding claim 3, Schaffer discloses the fabric reinforced prosthetic liner (100) of claim 1 (as described above) but fails to disclose at least one void containing a sensor. However, Janusson discloses a prosthetic liner (10) with an inner layer (18) made of silicone [0038] and teaches at least one void (22) containing a sensor (see par. [0035] and [0038] that the sensors 12, 14, 16 are in a groove, channel, or pocket 22 of the liner).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the prosthetic liner of Schaffer to include a void containing a sensor as the addition of a sensor allows for diagnostic or physiological measurements to be gathered over a period of time to be used for maximizing comfort and use of the prosthesis as taught by Janusson [0022-0035].
Regarding claim 11, Schaffer discloses the fabric reinforced prosthetic liner (100) of Claim 9 (as described above) but fails to disclose at least one void containing a sensor. However, Janusson discloses a prosthetic liner (10) with an inner layer (18) made of silicone [0038] and teaches at least one void (22) containing a sensor (see par. [0035] and [0038] that the sensors 12, 14, 16 are in a groove, channel, or pocket 22 of the liner).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the prosthetic liner of Schaffer to include a void containing a sensor as the addition of a sensor allows for diagnostic or physiological measurements to be gathered over a period of time to be used for maximizing comfort and use of the prosthesis as taught by Janusson [0022-0035].
Regarding claim 20, Schaffer discloses the fabric reinforced prosthetic liner (100) of Claim 16 (as described above) but fails to disclose at least one void containing a sensor. However, Janusson discloses a prosthetic liner (10) with an inner layer (18) made of silicone [0038] and teaches at least one void (22) containing a sensor (see par. [0035] and [0038] that the sensors 12, 14, 16 are in a groove, channel, or pocket 22 of the liner).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the prosthetic liner of Schaffer to include a void containing a sensor as the addition of a sensor allows for diagnostic or physiological measurements to be gathered over a period of time to be used for maximizing comfort and use of the prosthesis as taught by Janusson [0022-0035].
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Schaffer et al. (US 2005/0149202) as applied to claim 1 above, and further in view of Kelley et al. (US 2014/0277585).
Regarding claim 4, Schaffer discloses the fabric reinforced prosthetic liner of claim 1 (as described above) but fails to disclose the external fabric layer is a spacer fabric. However, Kelley discloses a prosthetic liner (1002) comprising an external fabric layer (1068) and teaches the external fabric layer (1068) is a spacer fabric (see par. [0088] disclosing that external layer is a 3D spacer fabric).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the external fabric material of Schaffer’s liner to include a spacer fabric as a spacer fabric provides a cushioning effect and improves moisture/air wicking capabilities as taught by Kelley [0089].
Claims 5-6, 12-13, and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Schaffer et al. (US 2005/0149202) in view of Laghi et al. (US 2013/0245786).
Regarding claim 5, Schaffer discloses the fabric reinforced prosthetic liner (100) of claim 1, wherein the thickness of the liner body (110) is between 1 millimeter and 18 millimeters (see par. [0048] disclosing that the total thickness of fabrics is between 0.01 inch and 0.20 inch, which is 0.254 mm and 5.08 mm). However, Schaffer fails to disclose thickness of the individual fabric layers, thereby fails to disclose the thickness of the knitted fabric is between 1 millimeter and 18 millimeters.
Laghi also discloses a prosthetic liner (Fig. 1) comprising an external fabric (3 and 3’) and an internal fabric (2 and 2’), with the internal fabric impregnated with the cushioning layer [0025]. Laghi teaches that the thickness of the individual fabrics could be between 0.3 mm and 1.5 mm [0024]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the range of the knitted fabric thickness of Schaffer with the range of individual fabric thickness of Laghi in order to achieve certain desirable characteristics (see par. [0024]). Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the knitted fabric thickness of Schaffer in view of Laghi from between 0.3 mm and 1.5 mm to between 1 millimeter and 18 millimeters as claimed since it has been held that “[i]n the case where the claimed ranges overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, applicant appears to have placed no criticality on the claimed range (see par. [00057] disclosing the thickness “generally” being within the claimed range).
Regarding claim 6, Schaffer discloses the fabric reinforced prosthetic liner (100) of claim 1, wherein the thickness of the liner body (110) is between 1 millimeter and 18 millimeters (see par. [0048] disclosing that the total thickness of fabrics is between 0.01 inch and 0.20 inch, which is 0.254 mm and 5.08 mm). However, Schaffer fails to disclose the specific individual thicknesses of the interior and exterior layers, thereby fails to disclose the interior fabric has a thickness between 0.1 millimeters and 2 millimeters.
Laghi also discloses a prosthetic liner (Fig. 1) comprising an external fabric (3 and 3’) and an internal fabric (2 and 2’), with the internal fabric impregnated with the cushioning layer [0025]. Laghi teaches that the thickness of the individual fabrics could be between 0.3 mm and 1.5 mm [0024]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the thickness range of the interior fabric of Schaffer with the range of fabric thickness of Laghi in order to achieve certain desirable characteristics (see par. [0024]). Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the interior fabric thickness of Schaffer in view of Laghi from between 0.3 mm and 1.5 mm to between 0.1 millimeter and 2 millimeters as claimed since it has been held that “[i]n the case where the claimed ranges overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, applicant appears to have placed no criticality on the claimed range (see par. [00058] disclosing the thickness is “on average…” between the claimed range).
Regarding claim 12, Schaffer discloses the fabric reinforced prosthetic liner (100) of claim 1, wherein the thickness of the liner body (110) is between 1 millimeter and 18 millimeters (see par. [0048] disclosing that the total thickness of fabrics is between 0.01 inch and 0.20 inch, which is 0.254 mm and 5.08 mm). However, Schaffer fails to disclose the specific individual thicknesses of the interior and exterior layers, thereby fails to disclose the thickness of the stitched fabric is between 1 millimeter and 18 millimeters.
Laghi also discloses a prosthetic liner (Fig. 1) comprising an external fabric (3 and 3’) and an internal fabric (2 and 2’), with the internal fabric impregnated with the cushioning layer [0025]. Laghi teaches that the thickness of the individual fabrics could be between 0.3 mm and 1.5 mm [0024]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the range of stitched fabric thickness of Schaffer with the range of individual fabric thickness of Laghi in order to achieve certain desirable characteristics (see par. [0024]). Further it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the stitched fabric thickness of Schaffer in view of Laghi from between 0.3 mm and 1.5 mm to between 1 millimeter and 18 millimeters as claimed since it has been held that “[i]n the case where the claimed ranges overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, applicant appears to have placed no criticality on the claimed range (see par. [00057] disclosing the thickness “generally” being within the claimed range)
Regarding claim 13, Schaffer discloses the fabric reinforced prosthetic liner (100) of claim 1, wherein the thickness of the liner body (110) is between 1 millimeter and 18 millimeters (see par. [0048] disclosing that the total thickness of fabrics is between 0.01 inch and 0.20 inch, which is 0.254 mm and 5.08 mm). However, Schaffer fails to disclose the specific individual thicknesses of the interior and exterior layers, thereby fails to disclose the interior fabric has a thickness between 0.1 millimeters and 2 millimeters.
Laghi also discloses a prosthetic liner (Fig. 1) comprising an external fabric (3 and 3’) and an internal fabric (2 and 2’), with the internal fabric impregnated with the cushioning layer [0025]. Laghi teaches that the thickness of the individual fabrics could be between 0.3 mm and 1.5 mm [0024]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the thickness range of the interior fabric of Schaffer with the range of fabric thickness of Laghi in order to achieve certain desirable characteristics (see par. [0024]). Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the interior fabric thickness of Schaffer in view of Laghi from between 0.3 mm and 1.5 mm to between 0.1 millimeter and 2 millimeters as claimed since it has been held that “[i]n the case where the claimed ranges overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, applicant appears to have placed no criticality on the claimed range (see par. [00058] disclosing the thickness is “on average…” between the claimed range).
Regarding claim 18, Schaffer discloses the fabric reinforced prosthetic liner (100) of claim 1, wherein the thickness of the liner body (110) is between 1 millimeter and 18 millimeters (see par. [0048] disclosing that the total thickness of fabrics is between 0.01 inch and 0.20 inch, which is 0.254 mm and 5.08 mm). However, Schaffer fails to disclose the specific individual thicknesses of the interior and exterior layers, thereby fails to disclose the thickness of the fabric is between 1 millimeter and 18 millimeters.
Laghi also discloses a prosthetic liner (Fig. 1) comprising an external fabric (3 and 3’) and an internal fabric (2 and 2’), with the internal fabric impregnated with the cushioning layer [0025]. Laghi teaches that the thickness of the individual fabrics could be between 0.3 mm and 1.5 mm [0024]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the range of fabric thickness of Schaffer with the range of individual fabric thickness of Laghi in order to achieve certain desirable characteristics (see par. [0024]). Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the fabric thickness of Schaffer in view of Laghi from between 0.3 mm and 1.5 mm to between 1 millimeter and 18 millimeters as claimed since it has been held that “[i]n the case where the claimed ranges overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, applicant appears to have placed no criticality on the claimed range (see par. [00057] disclosing the thickness “generally” being within the claimed range)
Regarding claim 19, Schaffer discloses the fabric reinforced prosthetic liner (100) of claim 1, wherein the thickness of the liner body (110) is between 1 millimeter and 18 millimeters (see par. [0048] disclosing that the total thickness of fabrics is between 0.01 inch and 0.20 inch, which is 0.254 mm and 5.08 mm). However, Schaffer fails to disclose the specific individual thicknesses of the interior and exterior layers, thereby fails to disclose the interior fabric has a thickness between 0.1 millimeters and 2 millimeters.
Laghi also discloses a prosthetic liner (Fig. 1) comprising an external fabric (3 and 3’) and an internal fabric (2 and 2’), with the internal fabric impregnated with the cushioning layer [0025]. Laghi teaches that the thickness of the individual fabrics could be between 0.3 mm and 1.5 mm [0024]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the thickness range of the interior fabric of Schaffer with the range of fabric thickness of Laghi in order to achieve certain desirable characteristics (see par. [0024]). Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the interior fabric thickness of Schaffer in view of Laghi from between 0.3 mm and 1.5 mm to between 0.1 millimeter and 2 millimeters as claimed since it has been held that “[i]n the case where the claimed ranges overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, applicant appears to have placed no criticality on the claimed range (see par. [00058] disclosing the thickness is “on average…” between the claimed range).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Schaffer et al. (US 2005/0149202) as applied to claim 16 above, and further in view of Colvin et al. (US 2009/0240344).
Regarding claim 17, Schaffer discloses the fabric reinforced prosthetic liner (100) of claim 16 (as described above) but fails to disclose a secondary inner thermoplastic layer. However, Colvin discloses a prosthetic liner (60) comprising a first inner thermoplastic layer (65) and teaches a secondary inner thermoplastic layer (70; [0040]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Schaffer’s prosthetic liner to include a secondary inner thermoplastic layer as the addition of a secondary layer enhances comfort and cushion, increases durability, and improves liner shape retention of the liner as taught by Colvin [0015].
Conclusion
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/Elizabeth A Melcher/Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774
