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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “divots”, “dimples” and the “locking teeth” must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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, 4, 10-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over McCarthy (WO2018/055411A1) in view of Bernhardt (FR2962327A1) and in view of Haberman (WO9734548A2).
In regard to claim 1, McCarthy teaches a prosthetic liner 1 comprising:
a substantially tubular fabric covering 5
having an open proximal end, a closed distal end, (pg 4, lines 14-15: liner is closed at their distal end and open at the proximal end; further this is within the definition of a prosthetic liner)
and an internal elastomer layer 1 (pg 7, line 10: silicone body),
wherein the closed distal end 9 further comprises a liner opening 19 (fig 1);
a locking attachment (combination of 15 and 31 together) further comprising
an umbrella 7,
an exterior screw cap 3, and a central aperture 31,
wherein the umbrella 7 further comprises a stem 15 and a base 11;
and wherein the umbrella 7 is adhered to the internal elastomer layer 1 once the exterior screw cap 3 is engaged with the umbrella 7 by joining the screw cap threads with the stem threads (27 and 15 fit together to combine the two; see figure 1). The claim language does not require 7 to be detached from the liner at any point, only in an adhered position during the combination.
However, McCarthy does not teach the exterior screw cap has screw cap threads and the stem has threading or that the distal end of the liner is dome-shaped.
Bernhardt teaches an external thread on a liner stem (E) in order to combine another prosthetic part to the liner (fig 1).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the threaded connection of Bernhardt between the two components of McCarthy (with the externally threaded component on the liner) and complimentary threads on the stem of attaching cap (see complimentary threads within F) in order to provide a more secure connection between the parts.
Haberman teaches the distal end of the liner is dome-shaped (see fig 6).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to make the distal end of the liner of McCarthy dome shaped as taught by Haberman in order to adapt the liner for the shape of the residual limb of the individual user.
In regard to claim 4, McCarthy meets the claim limitations as discussed in the rejection of claim 1 and further teaches the internal elastomer layer comprises silicone. (pg 7, line 10: silicone body)
In regard to claim 10, McCarthy meets the claim limitations as discussed in the rejection of claim 1 and further teaches the umbrella 7 is not embedded in the internal elastomer layer. (pg 7, line 11: “an end cap is fixed to a distal end 9 of liner 1) Fixed to is not the same as embedded and the umbrella 7 in figure 1 is external to the liner and therefore not embedded within the liner gel.
In regard to claim 11, McCarthy meets the claim limitations as discussed in the rejection of claim 1 and further teaches the umbrella 7 and the exterior screw cap 3 do not crimp the fabric 5 covering once engaged. (See figure 1, 4a; the fabric layer 4 does not extend between the umbrella and cap and therefore will be unaffected by their connection)
In regard to claim 12, McCarthy meets the claim limitations as discussed in the rejection of claim 1 but does not teach the central aperture 31 is internally threaded.
Bernhardt teaches an external thread on a liner stem (E) and an internal thread on a mating component F; (fig 1) in order to combine another prosthetic part to the liner (fig 1).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the threaded connection of Bernhardt between the liner stem and central aperture of McCarthy in order to provide a more secure connection between the parts than an interference fit.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over
McCarthy (WO2018/055411A1) in view of Bernhardt (FR2962327A1) and in view of Haberman (WO9734548A2) and further in view of Jacobs (5746772A).
In regard to claim 2, McCarthy meets the claim limitations as discussed in the rejection of claim 1 but does not teach the base of the umbrella is dome-shaped to correspond to the dome-shaped distal end.
Jacobs teaches the base of the umbrella 12A is dome-shaped to correspond to the dome-shaped distal end (of the liner; see fig 1).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the dome shape of Jacobs in the umbrella and liner distal end of McCarthy because this assists in distributing forces (Col 5, lines 28-30).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over
McCarthy (WO2018/055411A1) in view of Bernhardt (FR2962327A1) and in view of Haberman (WO9734548A2) and further in view of Schaffer (2005/0149202A1).
In regard to claim 5, McCarthy meets the claim limitations as discussed in the rejection of claim 1 but does not teach the internal elastomer layer comprises a thermoplastic styrene based elastomer gel.
Schaffer teaches the internal elastomer layer comprises a thermoplastic styrene-based elastomer gel. [0058: styrene and any thermoplastic elastomer blended with mineral oil).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the liner gel of Schaffer in place of the silicone liner gel of McCarthy because the added mineral oil component will improve skin health and reduce pressure points.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over
McCarthy (WO2018/055411A1) in view of Bernhardt (FR2962327A1) and in view of Haberman (WO9734548A2) and further in view of Eberle (2003/0181989A1).
In regard to claim 3, McCarthy meets the claim limitations as discussed in the rejection of claim 1 but does not teach the umbrella 7 and the screw cap comprise aluminum.
Eberle teaches the umbrella and the exterior screw cap comprise aluminum. [0035: the receptable body can be formed of aluminum]
Accordingly, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the aluminum material of the connector of the liner/umbrella of Eberle in the connectors (screw cap and stem threads) of McCarthy for durability and strength compared to elastomer.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over
McCarthy (WO2018/055411A1) in view of Bernhardt (FR2962327A1) and in view of Haberman (WO9734548A2) and further in view of Joseph (2022/0370214A1) and further in view of Crowther (2113425A).
In regard to claim 6, McCarthy meets the claim limitations as discussed in the rejection of claim 1 but the combination of McCarthy in view of Bernhardt does no teach the exterior screw cap 3 engages the umbrella 7 with locking teeth and a thread lock.
Joseph teaches applying a thread lock (interpreted as best understood to refer to a substance such as LOCTITE or similar) to a threaded connection. [0230: thread lock is applied to screws]
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to apply the thread lock of Joseph to the threaded connection of McCarthy in view of Bernhardt to prevent the screws from backing out. This is very common and well known in the art of prosthetics.
Crowther teaches a threaded connection which engages with locking teeth 36b (fig 16).
It would have been obvious to one of ordinary skill in the art of connectors at the time the invention was filed to use the locking washer of Crowther between the exterior screw cab and umbrella of McCarthy in view of Bernhardt because this provides an effective lock between the two components (Col 2, lines 1-6) and is able to accommodate various widths of clamping surfaces (Col 2, lines 20-25).
The figures only appear to show a threaded connection and not actual locking teeth. Refer to the drawing objection above.
Claim(s) 7-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over
McCarthy (WO2018/055411A1) in view of Bernhardt (FR2962327A1) and in view of Haberman (WO9734548A2) and further in view of Slemker (8308816B2).
In regard to claim 7, McCarthy meets the claim limitations as discussed in the rejection of claim 1 but does not teach the base 11 comprises a plurality of radial grooves on an upper face. As best understood from the instant disclosure (fig 3C) the upper face is actually the distal face when applied to the liner.
Slemker teaches the base further comprises a plurality (defined as two or more) of radial grooves 144, 141 on an upper face. (fig 4)
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the grooves of Slemker on the base/cap of McCarthy because the corresponding grooves and protrusions allow a seal between components (Col 5, lines 49-65) and prevent rotation.
In regard to claim 8, McCarthy meets the claim limitations as discussed in the rejection of claim 1 but does not teach the base 11 comprises a plurality of dimples on an upper face. As best understood from the instant disclosure (fig 3C) the upper face is actually the distal face when applied to the liner.
Slemker teaches the base further comprises a plurality (defined as two or more) of dimples 141, 139 on an upper face. (fig 4)
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the grooves of Slemker on the base/cap of McCarthy because the corresponding grooves and protrusions allow a seal between components (Col 5, lines 49-65) and prevent rotation.
In regard to claim 9, McCarthy meets the claim limitations as discussed in the rejection of claim 1 but does not teach the base further comprises a plurality of randomly placed divots on an upper face. As best understood from the instant disclosure (fig 3C) the upper face is actually the distal face when applied to the liner.
Slemker teaches the base further comprises a plurality (defined as two or more) of divots 141, 144 on an upper face.
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the grooves of Slemker on the base/cap of McCarthy because the corresponding grooves and protrusions allow a seal between components (Col 5, lines 49-65) and prevent rotation.
However, the combination of McCarthy in view of Slemker does not teach the divots are randomly placed.
It has been held that a mere rearrangement 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 divots of McCarthy in view of Slemker in a random design rather than patterned as it appears either arrangement 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 2144.04VIC
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over
McCarthy (WO2018/055411A1) in view of Bernhardt (FR2962327A1) and in view of Haberman (WO9734548A2) and in view of Slemker (8308816B2) and further in view of Eberle (2003/0181989A1).
In regard to claim 13, McCarthy teaches a prosthetic liner 1 comprising:
a substantially tubular fabric covering 5
having an open proximal end, a distal end, (pg 4, lines 14-15: liner is closed at their distal end and open at the proximal end; further this is within the definition of a prosthetic liner)
and an internal silicone layer (col 7, line 10: silicone body),
wherein the closed distal end further comprising a liner opening 19 (fig 1);
a locking attachment (combination of 15 and 31 together) further comprising an umbrella 7,
an exterior screw cap 3, and a central aperture 31,
wherein the umbrella 7 is not embedded in the internal silicone layer and further comprises a stem 15 and a base (outer ring of 7) (attached as shown in figures 1 and 4a and not within the gel therefore not embedded);
and wherein the umbrella 7 is adhered to the internal silicone layer (silicone layer of 1) once the exterior screw cap 3 is engaged with the umbrella by joining the screw cap with the stem (fig 4a; the claim does not require the umbrella is separate from the liner, only that the umbrella is adhered during engagement).
However, McCarthy does not teach the screw cap and stem are threaded to joint the umbrella and screw cap together, that the umbrella is aluminum or that the base comprises a plurality of radial grooves on the face or that the distal end is dome shaped.
Slemker teaches the base further comprises a plurality (defined as two or more) of radial grooves 144, 141 on an upper face. (fig 4)
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the grooves of Slemker on the base/cap of McCarthy because the corresponding grooves and protrusions allow a seal between components (Col 5, lines 49-65) and prevent rotation.
Eberle teaches the umbrella and the exterior screw cap comprise aluminum. [0035: the receptable body can be formed of aluminum]
Accordingly, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the aluminum material of the connector of the liner/umbrella of Eberle in the connectors (screw cap and stem threads) of McCarthy for durability and strength compared to elastomer.
Bernhardt teaches an external thread on a liner stem (E) in order to combine another prosthetic part to the liner (fig 1).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the threaded connection of Bernhardt between the two components of McCarthy (with the externally threaded component on the liner) and complimentary threads on the attaching cap (see complimentary threads within F) in order to provide a more secure connection between the parts than an interference fit.
Haberman teaches the distal end of the liner is dome-shaped (see fig 6).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to make the distal end of the liner of McCarthy dome shaped as taught by Haberman in order to adapt the liner for the shape of the residual limb of the individual user.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over
McCarthy (WO2018/055411A1) in view of Bernhardt (FR2962327A1) and in view of Haberman (WO9734548A2) in view of Schaffer (2005/0149202A1) in view of Slemker (8308816B2) and further in view of Eberle (2003/0181989A1).
In regard to claim 14, McCarthy teaches a prosthetic liner 1 comprising:
a substantially tubular fabric 5 covering having an open proximal end, a closed distal end, (pg 4, lines 14-15: liner is closed at their distal end and open at the proximal end; further this is within the definition of a prosthetic liner)
and an internal elastomer gel layer (col 7, line 10: silicone body),
wherein the closed distal end further comprising a liner opening 19 (see fig 1);
a locking attachment (combination of 15 and 31 together) further comprising an umbrella 7,
an exterior screw cap 3,
and a central aperture 31,
wherein the umbrella 7 is not embedded in the internal elastomer gel layer (gel of 1; as shown in figures 1 and 4a, the umbrella 7 is not embedded within the gel of 1)
and further comprises a stem 15 a base (outer portion of 7);
and wherein the umbrella 7 is adhered to the internal elastomer gel layer once the exterior screw cap 3 is engaged with the umbrella 7 by joining the screw cap threads with the stem threads. (fig 4a; the claim does not require the umbrella is separate from the liner, only that the umbrella is adhered during engagement).
However, McCarthy does not teach that the elastomer gel is a thermoplastic styrene based, that the distal end of the liner is dome-shaped, that the umbrella stem is threaded and joined with the umbrella by joining screw cap threads with stem threads, or that the base further comprises a plurality of radial grooves or that the umbrella is aluminum.
Bernhardt teaches an external thread on a liner stem (E) in order to combine another prosthetic part to the liner (fig 1).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the threaded connection of Bernhardt between the two components of McCarthy (with the externally threaded component on the liner) and complimentary threads on the attaching cap (see complimentary threads within F) in order to provide a more secure connection between the parts than an interference fit.
Schaffer teaches the internal elastomer layer comprises a thermoplastic styrene-based elastomer gel. [0058: styrene and any thermoplastic elastomer blended with mineral oil).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the liner gel of Schaffer in place of the silicone liner gel of McCarthy because the added mineral oil component will improve skin health and reduce pressure points.
Slemker teaches the base further comprises a plurality (defined as two or more) of radial grooves 144, 141 on an upper face. (fig 4)
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the grooves of Slemker on the base/cap of McCarthy because the corresponding grooves and protrusions allow a seal between components (Col 5, lines 49-65) and prevent rotation.
Eberle teaches the umbrella and the exterior screw cap comprise aluminum. [0035: the receptable body can be formed of aluminum]
Accordingly, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the aluminum material of the connector of the liner/umbrella of Eberle in the connectors (screw cap and stem threads) of McCarthy for durability and strength compared to elastomer.
Haberman teaches the distal end of the liner is dome-shaped (see fig 6).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to make the distal end of the liner of McCarthy dome shaped as taught by Haberman in order to adapt the liner for the shape of the residual limb of the individual user.
Conclusion
Also see Song (KR20100044956A) which is relevant prior art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTIE BAHENA whose telephone number is (571)270-3206. The examiner can normally be reached M-F 9-3.
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/CHRISTIE BAHENA/Primary Examiner, Art Unit 3774