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 .
Claim Objections
Claims 2-6 and 10-11 are objected to because of the following informalities:
Each of claims 2, 3, 10, and 11 recite “the synthetic fiber” which lacks antecedent basis and appears to be referring to – the breathable fiber –, as recited in claims 1 and 9.
Claims 4-6 recite “the elastomeric material” which appears to be referring to – the impermeable elastomeric material –, as recited in claim 1.
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.
Claims 10-13 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.
Claim 10 depends from itself and is therefore indefinite. For the purpose of further examination, claim 10 is interpreted to depend from claim 9.
Claims 11-13 include terms that are lacking antecedent basis. For the purpose of further examination, claims 11-13 are interpreted to depend from claim 9.
Claim Rejections - 35 USC § 102
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.
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.
Claim(s) 1 and 4 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent Application Publication No. 2005/0267599 A1 to Bjarnason (Bjarnason).
Regarding at least claim 1
Bjarnason teaches a close-ended residual limb suspension liner that includes a center portion extending between the distal and proximal portions (abstract).
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Bjarnason meets the limitations of a suspension interface (fig. 22) comprising: a tubular stretchable fabric layer (102) comprising a breathable fiber having an open proximal end and closed distal end (paragraph 0012 discloses a tubular shaped elasticized fabric defining an open-ended tubular sleeve; fabric is defined as: a cloth produced by weaving or knitting fibers, and therefore comprises a breathable fiber as claimed); at least one sealing element (110) bonded to the tubular stretchable fabric layer at an intermediate region and comprising a sealing element base (112) and a single engaging member (114) which extends radially outward (paragraphs 0081-0083 and fig. 22); and an internal grip layer located on an inner face of the tubular stretchable fabric layer further comprising an impermeable elastomeric material (paragraph 0087 discloses a layer of silicone elastomer formed on the internal surface of the liner).
Regarding at least claim 4
Bjarnason teaches the suspension interface of Claim 1 wherein the elastomeric material is silicone (paragraph 0087 discloses that the elastomeric material is silicone).
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) 2, 3, 7, 9-12, and 14-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bjarnason in view of US Patent Application Publication No. 2005/0149202 A1 to Schaffer et al. (Schaffer).
Regarding at least claim 9
Bjarnason meets the limitations of a suspension interface (fig. 22) comprising: a tubular stretchable fabric layer comprising a breathable fiber having an open proximal end and closed distal end (paragraph 0012 discloses a tubular shaped elasticized fabric defining an open-ended tubular sleeve; fabric is defined as: a cloth produced by weaving or knitting fibers, and therefore comprises a breathable fiber as claimed); at least one sealing element (110) bonded to the tubular stretchable fabric layer at an intermediate region (fig. 22) and comprising a sealing element base (112) and a single engaging member (114) which extends radially outward (paragraphs 0081-0083 and fig. 22); and an external grip layer located on an exterior face of the tubular stretchable fabric layer above the sealing element (paragraph 0088 discloses an elasticity controlling matrix material provided on the exterior of the liner which prevents movement of liner when a prosthesis is worn thereover). However, Bjarnason does not explicitly teach that the external grip layer further comprises silicone.
Schaffer teaches an improved liner for covering a residual limb of an amputee (abstract). Schaffer further teaches that the liner includes a coating (external grip layer; 200), for the purpose of limiting the elasticity of the liner at its distal end portion to thereby increase wear characteristics of the liner during normal use (paragraph 0062). Schaffer also teaches that suitable materials for the coating include silicones (paragraph 0067).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to specify that the external grip layer of Bjarnason, which is substantially rigid in an axial direction for preventing movement of liner when a prosthesis is worn thereover, further comprises silicone, in order to limit the elasticity of the liner to thereby increase wear characteristics of the liner during normal use, as taught by Schaffer.
Regarding at least claim 14
Bjarnason meets the limitations of a suspension interface (fig. 22) comprising: a tubular stretchable fabric layer (102) comprising a breathable synthetic fiber having an open proximal end and closed distal end (paragraph 0012 discloses a tubular shaped elasticized fabric defining an open-ended tubular sleeve; fabric is defined as: a cloth produced by weaving or knitting fibers, and therefore comprises a breathable fiber as claimed); at least one sealing element (110) bonded to the tubular stretchable fabric layer at an intermediate region (fig. 22) and comprising a sealing element base (112) and a single engaging member (114) which extends radially outward (fig. 22); an internal grip layer located on an inner face of the tubular stretchable fabric layer and comprising silicone (paragraph 0087 discloses an elastomeric material that is silicone formed on the internal surface of the liner); and an external grip layer located on an exterior face of the tubular stretchable fabric layer (paragraph 0088 discloses an elasticity controlling matrix material provided on the exterior of the liner which is substantially rigid in an axial direction for preventing movement of liner when a prosthesis is worn thereover). However, Bjarnason does not explicitly teach that the external grip layer further comprises silicone.
Schaffer teaches an improved liner for covering a residual limb of an amputee (abstract). Schaffer further teaches that the liner includes a coating (external grip layer; 200) for the purpose of limiting the elasticity of the liner at its distal end portion to thereby increase wear characteristics of the liner during normal use (paragraph 0062). Schaffer also teaches that suitable materials for the coating include silicones (paragraph 0067).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to specify that the external grip layer of Bjarnason, which is substantially rigid in an axial direction for preventing movement of liner when a prosthesis is worn thereover, further comprises silicone, in order to limit the elasticity of the liner to thereby increase wear characteristics of the liner during normal use, as taught by Schaffer.
Regarding at least claims 2, 10, and 15
Bjarnason teaches the suspension interface of Claim 1, and Bjarnason in view of Schaffer teaches the suspension interface of claims 9 [see 112 rejection above] and 14. Bjarnason also teaches a tubular stretchable fabric layer comprising a breathable synthetic fiber. However, Bjarnason does not explicitly teach that the synthetic fiber is nylon.
Schaffer teaches a liner made of textile material, such as nylon and polyester, for the purpose of permitting stretch during normal application of the liner to the residual limb and as the wearer moves the prosthetic limb (paragraphs 0044 and 0046).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to specify that the synthetic fiber of Bjarnason is nylon, since this material is well known in the art for permitting stretch during normal application of the liner to the residual limb and as the wearer moves the prosthetic limb, as taught by Schaffer.
Regarding at least claims 3, 11, and 16
Bjarnason teaches the suspension interface of Claim 1, and Bjarnason in view of Schaffer teaches the suspension interface of claims 9 [see 112 rejection above] and 14. Bjarnason also teaches a tubular stretchable fabric layer comprising a breathable synthetic fiber. However, Bjarnason does not explicitly teach wherein the synthetic fiber is polyester.
Schaffer teaches a liner made of textile material, such as nylon and polyester, for the purpose of permitting stretch during normal application of the liner to the residual limb and as the wearer moves the prosthetic limb (paragraphs 0044 and 0046).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to specify that the synthetic fiber of Bjarnason is polyester, since this material is well known in the art for permitting stretch during normal application of the liner to the residual limb and as the wearer moves the prosthetic limb, as taught by Schaffer.
Regarding at least claims 7 and 17
Bjarnason teaches the suspension interface of Claim 1 and Bjarnason in view of Schaffer teaches the suspension interface of claim 14. Bjarnason also teaches the internal grip layer having a thickness. However, Bjarnason does not teach wherein the thickness is between is 1/64 inch (0.015 inch) and 1 inch.
Schaffer teaches applying a cushioning material (120; internal grip layer) to the interior surfaces of the a liner while controlling the thickness of the material, for the purpose of permitting contouring of the cushioning material to provide additional comfort to the wearer as is the case in some of the sensitive interface locations between the residual limb and the prosthetic device, etc. (paragraph 0050). Schaffer also teaches a thickness of the liner from about 0.010 inch to about 0.200 inch (paragraph 0048).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to specify that the internal grip layer thickness is controlled when being applied such that the liner maintains a thickness from about 0.010 inch to about 0.200 inch, in order to permit contouring and thereby provide additional comfort to the wearer as necessary, as taught by Schaffer.
However, Schaffer does not explicitly wherein the thickness between is 1/64 inch (0.015 inch) and 1 inch.
It would further have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to specify that the controlled thickness of the internal grip layer of Schaffer is between 1/64 inch (0.015 inch) and 1 inch as applicant appears to have placed no criticality on the claimed range (see pp. [0073] indicating the thickness “can” be within the claimed range) and 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).
Regarding at least claims 12 and 18
Bjarnason in view of Schaffer teaches the suspension interface of Claims 9 [see 112 rejection above], and 14. Bjarnason also teaches the external grip layer having a thickness. However, Bjarnason does not explicitly teach wherein the thickness is between 1/64 inch (0.015 inch) and 1 inch.
Schaffer also teaches a coating (external grip layer) on the external surface of a liner that has a thickness on the order of about 0.010 inch to about 0.090 inch, for the purpose of having an ability to change shape and also strength the fabric liner (paragraph 0066).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the thickness of the external grip layer of Bjarnason to be on the order of about 0.010 inch to about 0.090 inch, in order to ensure the ability of the liner to change shape while also strengthening the fabric liner, as taught by Schaffer.
It would further have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the thickness of Schaffer from between about 0.010 inch to about 0.090 to between 1/64 inch (0.015 inch) and 1 inch as applicant appears to have placed no criticality on the claimed range (see pp. [0019] indicating the thickness “can” be within the claimed range) and 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).
Claim(s) 5, 6, and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bjarnason, as applied to claim 1 above, in view of US Patent Application Publication No. 2010/0274363 A1 to Laghi et al. (Laghi).
Regarding at least claim 5
Bjarnason teaches the suspension interface of Claim 1, including the elastomeric material. However, Bjarnason does not teach wherein the elastomeric material is a thermoplastic elastomer comprising styrene blocks.
Laghi teaches preferred fabrics for a liner that comprises a layer of elastomeric material, for example polyurethanes and block copolymers such as styrene block copolymers, for the purpose of enduring long periods of dynamic wearer contact (paragraph 0035).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to specify that the elastomeric material of Bjarnason is a thermoplastic elastomer comprising styrene blocks, in order to endure long periods of dynamic wearer contact, as taught by Laghi.
Regarding at least claim 6
Bjarnason teaches the suspension interface of Claim 1, including the elastomeric material. However, Bjarnason does not teach wherein the elastomeric material is urethane.
Laghi teaches preferred fabrics for a liner that comprises a layer of elastomeric material, for example polyurethanes and block copolymers such as styrene block copolymers, for the purpose of enduring long periods of dynamic wearer contact (paragraph 0035).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to specify that the elastomeric material of Bjarnason is urethane, in order to endure long periods of dynamic wearer contact, as taught by Laghi.
Regarding at least claim 8
Bjarnason teaches the suspension interface of Claim 1, including the tubular stretchable fabric layer. However, Bjarnason does not explicitly teach wherein the tubular stretchable fabric layer further comprises an elastic yarn at the closed distal end to conform to a residual limb.
Laghi teaches preferred fabrics for a liner that include knit fabrics made from stretchable yarns, for the purpose of allowing the fabric to stretch in the longitudinal direction without causing measurable contraction in the transverse direction (paragraphs 0014 and 0038).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to specify that the tubular fabric of Bjarnason comprises an elastic yarn at the closed distal end to conform to a residual limb, in order to allow the fabric to stretch in the longitudinal direction without causing measurable contraction in the transverse direction, as taught by Laghi.
Claim(s) 13 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bjarnason in view of Schaffer, as applied to claims 9 [see 112 rejection above] and 14 above, and further in view of Laghi.
Bjarnason in view of Schaffer teaches the interface of claims 9 [see 112 rejection above] and 14. Bjarnason also teaches that the liner includes the tubular stretchable fabric layer. However, Bjarnason does not explicitly teach wherein the tubular stretchable fabric layer further comprises an elastic yarn at the closed distal end to conform to a residual limb.
Laghi teaches preferred fabrics for a liner that include knit fabrics made from stretchable yarns, for the purpose of allowing the fabric to stretch in the longitudinal direction without causing measurable contraction in the transverse direction (paragraphs 0014 and 0038).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to specify that the tubular fabric of Bjarnason comprises an elastic yarn at the closed distal end to conform to a residual limb, in order to allow the fabric to stretch in the longitudinal direction without causing measurable contraction in the transverse direction, as taught by Laghi.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA A HOBAN whose telephone number is (571)270-5785. The examiner can normally be reached Monday-Friday 8:00AM-5:00PM.
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/M.A.H/Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774