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 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 2-5 and 7-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Johnson (US Patent No. 11,622,870).
Regarding claim 2, Johnson discloses a reinforced prosthetic sock (Figure 1; column 6, lines 1-8) comprising:
an outer fabric layer (see Figure 1, item 119 “casting sock”) having a closed distal end and an open proximal end (the casting sock 119 is depicted in Figure 1 with a closed distal end and an open proximal end) wherein the closed distal end further comprises a centrally located channel (Figure 1, column 8, line 24-28, discloses that the casting sock 119 is applied to fit over the inner coupling member 115, the distal pad 113, and at least part of the flexible sheath 117, the separator bag 111, and the sock 105 when those components are in position with the person's stump, these things are all in the centrally located channel of the closed distal end); and
a fabric disc (Figures 1 and 4, item 112) comprising a disc channel (Figures 1 and 4, item 121c) and an interior disc rim (Figures 1 and 4, item 121d),
wherein the fabric disc (Figures 1 and 4, item 121) is attached to the closed distal end layer (column 10, lines 39-51; column 11, lines 48-49) such that the centrally located channel and the disc channel create a concentric central channel (when the disc channel 121 is glued to closed distal end of the outer fabric layer of the cured casting sock 119, the channels will create a concentric central channel).
Regarding claim 3, Johnson discloses wherein the fabric disc further comprises polyester (column 8, lines 51-56, polyethylene terephthalate is a polyester).
Regarding claim 4, Johnson discloses wherein the fabric disc is circular (Figures 1 and 4, item 121).
Regarding claim 5, Johnson discloses wherein the fabric disc has an outer diameter between 0.5 and 4 inches (column 8, lines 48-50).
Regarding claim 7, Johnson discloses wherein the fabric disc (Figures 1 and 4, item 121) is glued to the closed distal end of the outer fabric layer (column 10, lines 39-51; column 11, lines 48-49) such that the centrally located channel and the disc channel create a concentric central channel (when the disc channel 121 is glued to closed distal end of the outer fabric layer of the cured casting sock 119, the channels will create a concentric central channel).
Regarding claim 8, Johnson discloses wherein the central channel is devoid of glue (column 11, lines 48-49 discloses that the glue 131 is provided between the outer region of cured casting sock 119 and upper inner surface 121a, therefore the interior disc rim 121d, interior fabric rim (Figure 1, item 105) and central channel (121d of fabric disc and inner channel of cured casting sock 119 would be devoid of glue).
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 1, 6, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson (US Patent No. 11,622,870).
Regarding claim 1, Johnson discloses a reinforced prosthetic sock (Figure 1; column 6, lines 1-8) comprising:
an outer fabric layer (see Figure 1, item 119 “casting sock”) having a closed distal end and an open proximal end (the casting sock 119 is depicted in Figure 1 with a closed distal end and an open proximal end) wherein the closed distal end further comprises a centrally located channel having an interior fabric rim (Figure 1, column 8, line 24-28, discloses that the casting sock 119 is applied to fit over the inner coupling member 115, the distal pad 113, and at least part of the flexible sheath 117, the separator bag 111, and the sock 105 when those components are in position with the person's stump, these things are all in the centrally located channel of the closed distal end with an interior fabric rim (sock 105)); and
a fabric disc (Figure 1, item 121; column 6, lines 38-56; Figures 4 and 5 depict outer coupler 121, the reference numbers 115 and 121 are used interchangeably, although they are different components) comprising a disc channel (Figures 1 and 4, item 121c), an interior disc rim (Figures 1 and 4, item 121d), and an outer diameter between 0.5 and 4 inches (column 8, lines 48-50),
wherein the fabric disc (Figures 1 and 4, item 121) further comprises polyester (column 8, lines 51-56, polyethylene terephthalate is a polyester) is circular (Figures 1 and 4, item 121), the fabric disc being glued to the closed distal end of the outer fabric layer (column 10, lines 39-51; column 11, lines 48-49) such that the centrally located channel and the disc channel create a concentric central channel (when the disc channel 121 is glued to closed distal end of the outer fabric layer of the cured casting sock 119, the channels will create a concentric central channel),
the central channel having an inner diameter between 0.25 and 1 inches (column 8, lines 50-51, Johnson discloses that the inner diameter is 1 1/8 inch. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Johnson by making the central channel 121c having an inner diameter between 0.25 and 1 inches because the central channel would continue to function to receive the artificial limb, optimizing the diameter would be a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).)
and wherein the central channel, interior disc rim, and interior fabric rim are devoid of glue (column 11, lines 48-49 discloses that the glue 131 is provided between the outer region of cured casting sock 119 and upper inner surface 121a, therefore the interior disc rim 121d, interior fabric rim (Figure 1, item 105) and central channel (121d of fabric disc and inner channel of cured casting sock 119 would be devoid of glue).
Johnson does not specifically disclose that the fabric disc has a horizontal stretch 20% less than the outer fabric layer. However, Johnson does disclose wherein the fabric disc is polyester and that the outer fabric layer (i.e. flexible sheath 117) is made to elastically hold the separator bag 111 with the inner coupling member 115 and distal pad 113 therein tightly upon the sock 115. Tighter may refer to being harder to be removed from a person's stump or foot compared to the sock 105. Tightly refers to the situation that the person wearing the flexible sheath 117 feels that the flexible sheath 117 exerts more pressure on the person's stump or foot compared to the sock 105 (see Johnson, column 7, line 66- column 8, line 12). Therefore, Johnson discloses the need for the outer fabric layer having a greater horizontal stretch than the fabric disc. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the outer fabric layer by providing wherein the fabric disc has a horizontal stretch 20% less than the outer fabric layer as taught by Johnson because this would provide for an outer fabric layer that will provide more pressure on the person’s stump or foot to hold the outer fabric layer in place. Furthermore, the applicant’s specification does not provide criticality that the fabric disc being a horizontal stretch 20% less than the outer fabric layer is significant and not merely a trivial aspect of the prior art. It has not been demonstrated that the claimed range produces unexpected results or has a critical property that a person of ordinary skill in the art would not have expected.
Regarding claim 6, Johnson discloses wherein the central channel has an inner diameter of 1 1/8 inch (column 8, lines 50-51, Johnson discloses that the inner diameter is 1 1/8 inch.)
However, Johnson does not specifically disclose wherein the central channel has an inner diameter between 0.25 and 1 inches.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Johnson by making the central channel 121c having an inner diameter between 0.25 and 1 inches because the central channel would continue to function to receive the artificial limb, optimizing the diameter would be a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).).
Regarding claim 10, Johnson discloses the invention substantially as claimed.
However, Johnson does not specifically disclose wherein the fabric disc has a horizontal stretch 20% less than the outer fabric layer.
Johnson does disclose wherein the fabric disc is polyester and that the outer fabric layer (i.e. flexible sheath 117) is made to elastically hold the separator bag 111 with the inner coupling member 115 and distal pad 113 therein tightly upon the sock 115. Tighter may refer to being harder to be removed from a person's stump or foot compared to the sock 105. Tightly refers to the situation that the person wearing the flexible sheath 117 feels that the flexible sheath 117 exerts more pressure on the person's stump or foot compared to the sock 105 (see Johnson, column 7, line 66- column 8, line 12). Therefore, Johnson discloses the need for the outer fabric layer having a greater horizontal stretch than the fabric disc. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the outer fabric layer by providing wherein the fabric disc has a horizontal stretch 20% less than the outer fabric layer as taught by Johnson because this would provide for an outer fabric layer that will provide more pressure on the person’s stump or foot to hold the outer fabric layer in place. Furthermore, the applicant’s specification does not provide criticality that the fabric disc being a horizontal stretch 20% less than the outer fabric layer is significant and not merely a trivial aspect of the prior art. It has not been demonstrated that the claimed range produces unexpected results or has a critical property that a person of ordinary skill in the art would not have expected.
Claims 9 and 11-16 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson (US Patent No. 11,622,870) in view of Supaopashpun et al (US 2023/0149650 A1).
Regarding claim 9, Johnson discloses wherein the fabric disc is attached to the closed distal end of the outer fabric layer (column 11, lines 48-49) with a polyurethane adhesive (column 10, lines 39-42).
Johnson discloses a polyurethane adhesive, however, Johnson does not disclose wherein the polyurethane adhesive is heat activated.
Supaopashpun teaches the use of a heat activated polyurethane adhesive (see Supaopashpun, Figure 89, paragraph 0645, item 10150).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the polyurethane adhesive of Johnson by providing a heat activated polyurethane adhesive, as taught by Supaophashpun, because the results would be predictable. The adhesive would still be used to adhere the fabric disc to the closed distal end of the outer fabric layer except now it would be adhered with heat active polyurethane adhesive.
Regarding claim 11, Johnson discloses a reinforced prosthetic sock (Figure 1; column 6, lines 1-8) comprising:
an outer fabric layer (see Figure 1, item 119 “casting sock”) having a closed distal end and an open proximal end (the casting sock 119 is depicted in Figure 1 with a closed distal end and an open proximal end) wherein the closed distal end further comprises a centrally located channel (Figure 1, column 8, line 24-28, discloses that the casting sock 119 is applied to fit over the inner coupling member 115, the distal pad 113, and at least part of the flexible sheath 117, the separator bag 111, and the sock 105 when those components are in position with the person's stump, these things are all in the centrally located channel of the closed distal end);
and a fabric disc (Figure 1, item 121; column 6, lines 38-56; Figures 4 and 5 depict outer coupler 121, the reference numbers 115 and 121 are used interchangeably, although they are different components) comprising a disc channel (Figures 1 and 4, item 121c) and an interior disc rim (Figures 1 and 4, item 121d),
wherein the fabric disc (Figures 1 and 4, item 121) is attached to the closed distal end with a polyurethane adhesive ((column 10, lines 39-51; column 11, lines 48-49), and
wherein the fabric disc is attached such that the centrally located channel and the disc channel create a concentric central channel (when the disc channel 121 is glued to closed distal end of the outer fabric layer of the cured casting sock 119, the channels will create a concentric central channel).
Johnson discloses a polyurethane adhesive, however, Johnson does not disclose wherein the polyurethane adhesive is heat activated.
Supaopashpun teaches the use of a heat activated polyurethane adhesive (see Supaopashpun, Figure 89, paragraph 0645, item 10150).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the polyurethane adhesive of Johnson by providing a heat activated polyurethane adhesive as taught by Supaophashpun because the results would be predictable. The adhesive would still be used to adhere the fabric disc to the closed distal end of the outer fabric layer except now it would be adhered with heat active polyurethane adhesive.
Regarding claim 12, as set forth supra, the combination discloses wherein the fabric disc is circular (see Johnson, Figures 1 and 4, item 121).
Regarding claim 13, as set forth supra, the combination discloses wherein the fabric disc has an outer diameter between 0.5 and 4 inches (column 8, lines 48-50).
Regarding claim 14, as set forth supra, the combination discloses wherein the fabric disc has an inner diameter between 0.25 and 1 inches (see Johnson, column 8, lines 50-51, Johnson discloses that the inner diameter is 1 1/8 inch. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Johnson by making the central channel 121c having an inner diameter between 0.25 and 1 inches because the central channel would continue to function to receive the artificial limb, optimizing the diameter would be a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).). .
Regarding claim 15, as set forth supra, the combination discloses wherein the fabric disc further comprises polyester (column 8, lines 51-56, polyethylene terephthalate is a polyester).
Regarding claim 16, as set forth supra, the combination discloses the invention substantially as claimed.
However, the combination does not specifically disclose wherein the fabric disc has a horizontal stretch 20% less than the outer fabric layer.
Johnson does disclose wherein the fabric disc is polyester and that the outer fabric layer (i.e. flexible sheath 117) is made to elastically hold the separator bag 111 with the inner coupling member 115 and distal pad 113 therein tightly upon the sock 115. Tighter may refer to being harder to be removed from a person's stump or foot compared to the sock 105. Tightly refers to the situation that the person wearing the flexible sheath 117 feels that the flexible sheath 117 exerts more pressure on the person's stump or foot compared to the sock 105 (see Johnson, column 7, line 66- column 8, line 12). Therefore, Johnson discloses the need for the outer fabric layer having a greater horizontal stretch than the fabric disc. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the outer fabric layer by providing wherein the fabric disc has a horizontal stretch 20% less than the outer fabric layer as taught by Johnson because this would provide for an outer fabric layer that will provide more pressure on the person’s stump or foot to hold the outer fabric layer in place. Furthermore, the applicant’s specification does not provide criticality that the fabric disc being a horizontal stretch 20% less than the outer fabric layer is significant and not merely a trivial aspect of the prior art. It has not been demonstrated that the claimed range produces unexpected results or has a critical property that a person of ordinary skill in the art would not have expected.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA LYNEE ZIMMERMAN whose telephone number is (313)446-4864. The examiner can normally be reached Mon. 8:30 AM-6:30 PM, Tues. - Fri. 8:30-4:00 PM.
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/REBECCA LYNEE ZIMMERMAN/Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774