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 .
Status of Claims
Claims 1-9, 12-15, and 17-23 are pending and examined below
Response to Arguments
The remarks of 01/07/2026 have been fully considered but they are not persuasive.
Applicant argues that the prior art doesn't explicitly teach or disclose all of the elements of amended claim 1, in particular the following claim language
wherein the deposition apparatus further comprises a probe that is configured to detect an axis offset of the mandrel, wherein the deposition apparatus is configured to provide a mandrel offset correction by controlling corresponding movement of the nozzle based on the axis offset detected by the probe.
This argument is moot in light of the new 103 rejection below.
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 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0147875 A1 (Asgeirsson) in view of US 2017/0120522 A1 (Skubic)
Regarding claim 1, Asgeirsson discloses a system for additive manufacturing (Fig. 1, 100) using uncured liquid silicone (¶0055, wherein “uncured elastomeric material…. two-part silicone material” corresponds to uncured liquid silicone) received from a reservoir (Fig. 1, 102), comprising:
a deposition apparatus (Fig. 9, 306) comprising a nozzle (Fig. 11, 390), the deposition apparatus arranged to receive the uncured liquid silicone (¶0091, wherein 306 is arranged to received materials according to previously described embodiments, see also ¶0055, wherein uncured liquid silicone can be received); and
a deposition substrate (Fig. 9, 330) configured to receive the uncured liquid silicone deposited from the nozzle of the deposition apparatus (Fig. 9, ¶0095, wherein 330 is configured for this intended use because silicone is “deposited through the nozzle”), the deposition substrate (Fig. 9, 330) having a cylindrical or conical mandrel (Fig. 9, 336) defining an axis (see annotated Fig. 9 below), the mandrel arranged to rotate about the axis thereof (see annotated Fig. 9 below, wherein R9 corresponds to rotated about the axis), wherein the nozzle (Fig. 9, 390) is adapted to move relative to the axis of the mandrel (¶0096, wherein 390 is configured for the intended use because “306 may be configured to move and translate relative to 336”)
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Asgeirsson disclose a mandrel (see Fig. 9 above) and a deposition apparatus (Fig. 9, 330) doesn't explicitly teach or disclose a probe configured to detect an axis offset of the mandrel, wherien the deposition apparatus is configured to provide a mandrel offset correction by controlled corresponding movement of the nozzle based on the axis offset detected by the probe
Skubic discloses a system for additive manufacturing (Fig. 1) comprising a probe (Fig. 1, touch prob 118, ¶0063) configured to detect an axis offset of the mandrel (¶0063, wherein the touch probe is configured for this intended use because it “is used to accurately determine a current Z-position”), wherien the deposition apparatus is configured to provide a mandrel offset correction by controlled corresponding movement of the nozzle based on the axis offset detected by the probe (Page 2, ¶3, wherein “toolpath generation in our own pathplanning software, resulting in a compensated toolpath” corresponds to controlled corresponding movement of the nozzle based on the axis offset detected by the probe”
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the deposition apparatus of Asgeirsson with a probe, as taught by Skubic, in order to determine a Z-position of the nozzle (¶0063)
Claim(s) 2-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0147875 A1 (Asgeirsson) in view of US 2017/0120522 A1 (Skubic), as applied to claims above, and further in view of US 2016/0318247 (Schlachter)
Regarding claim 2, Asgeirsson discloses wherein the nozzle is configured to move relative to the axis of the mandrel (see rejection of claim 1 above) but doesn’t explicitly teach or disclose that the nozzle is arranged to be positioned offset relative to the axis. Skubic doesn't explicitly teach or disclose a nozzle is arranged to be positioned offset relative to the axis.
Schlachter discloses a system for additive manufacturing (Fig. 1,10) comprising: a nozzle (Fig. 1, 33) arranged to be positioned offset relative to the axis (Fig. 1, ¶0051, wherein 33 is configured for this intended use because there can be a gap between 30 and the printing surface 12, i.e. offset in the Z direction of Fig. 1)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the nozzle of Asgeirsson in view of Skubic to be positioning offset relative to the axis, as taught by Schlachter, in order provide a high level of customization of the prosthetic liner.
Regarding claim 3, Asgeirsson discloses a nozzle (see rejection of claim 1) but doesn’t explicitly teach or disclose a deposition apparatus with at least two nozzles. Skubic doesn't explicitly teach or disclose a deposition apparatus with at least two nozzles.
Schlachter discloses a deposition apparatus (Fig. 1, 30) with at least two nozzles (¶0056, wherein “multiple print heads” corresponds to at least two nozzles).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the deposition apparatus with of Asgeirsson in view of Skubic with at least two nozzles, as taught by Schlachter, in order to decrease the time required to dispense the elastomeric material therefore lowering overall production time.
Regarding claim 4, Asgeirsson discloses a nozzle arranged to deposit uncured liquid silicone onto a mandrel (see rejection of claim 1) but doesn’t explicitly teach or disclose at least two nozzles arranged in a predetermined configuration and configured to deposit simultaneously. Skubic doesn't explicitly teach or disclose at least two nozzles arranged in a predetermined configuration and configured to deposit simultaneously.
Schlachter discloses at least two nozzles (¶0059, wherein “multiple print heads” corresponds to at least two nozzles”) arranged in a predetermined configuration (See Fig. 6, for predetermined configuration of each print head) and configured to deposit simultaneously (¶0056, wherein multiple print heads 30 are configured for this intended use because they are “each configured to deposit material onto printing surface 12)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the system of Asgeirsson in view of Skubic with two nozzles arranged in a predetermined configuration and configured to deposit simultaneously, as taught by Schlachter, in order to decrease the time required to dispense the elastomeric material therefore lowering overall production time.
Regarding claim 5, Asgeirsson discloses a mandrel and a nozzle (see rejection of claim 1) but doesn’t explicitly teach or disclose at least two nozzles that move helically relative the axis of the mandrel. Skubic doesn't explicitly teach or disclose at least two nozzles that move helically relative the axis of the mandrel.
Schlachter discloses wherein the at least two nozzles (¶0056, wherein “multiple print heads 30” corresponds to at least two nozzles) move helically relative to the axis of the mandrel (Fig. 5, ¶0142, wherein 30 is configured for this intended use because the “wave-shaped strands 72” corresponds to a helical pattern)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify Asgeirsson in view of Skubic with at least two nozzles that move helically relative to the axis of the mandrel, as taught by Schlachter, in order to impart stretchability in at least a region of the prosthetic liner (¶0142).
Claim(s) 6-9, 11-14, 17-19, 22, and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2021/0137708 A1 (Orrason) in view of WO 2018055411 (McCarthy)
Regarding claim 6, Orrason discloses a prosthetic liner (Fig. 1, 102) forming a proximal end and a distal end, and a body defined between the proximal end and distal end, and the prosthetic liner having a tubular shape defined about an axis of the body (see Fig. 1, wherien 102 is a tubular body extending between a proximal and distal end) comprising:
an elastomeric body (Fig. 2, 116) defined by a lattice structure (Fig. 2, wherein 116 is arranged in a lattice structure, see also ¶0030, wherein “lattice-like network” corresponds to a lattice structure) including a first layer of first filaments (Fig. 3, 129) discretely formed from a first elastomeric material (¶0077, wherein filaments 129 are formed of an elastomeric material) and overlapping a second layer of second filaments (Fig. 5D, 143b) discretely formed from a second elastomeric material (¶0087, wherein silicone corresponds to an elastomeric material),
the first and second filaments of the first and second layers, respectively, overlapping and securing to one another at discrete intersections to form a first set of interstices located therebetween in a predetermined pattern (¶0029, “second sub-layer overlaps the first sub-layer and forms a plurality of interstices therebetween);
wherein the first and second layers are blended at least in part with one another in a blended region at an interface of the first and second layers, the blended region forming a permanent chemical bond (¶0035, “chemical bonding, so they are joined permanently”) in which the first and second elastomeric materials of the first and second layers of the first and second filaments intermix (¶0035);
an adhesive layer (Fig. 20, adhesive layer 374) deposited onto the elastomeric body (Fig. 20, 306) and layered onto at least a portion of an outermost surface of the elastomeric body (Fig. 20, wherein 374 is deposited onto 372)
Orasson doesn't explicitly teach or disclose an end cap formed from an elastomeric material secured to the distal end, wherein the elastomeric body defines a first recess that has a depth from an adjacent area of the elastomeric body, the adjacent area being proximal to the distal end, the adjacent area being proximal to the distal end. Wherein the depth corresponds to a thickness of the end cap such that the end cap does not protrude beyond contours of the elastomeric body including said adjacent area, wherein the first recess extends distally from the adjacent area about an entirety of the distal end of the elastomeric body.
McCarthy discloses a prosthetic liner (Fig. 1) comprising an end cap (Fig. 1, sealing cap 3) formed from an elastomeric material (Page 7, Line 32, “silicone”) secured to the distal end (see Fig. 1, wherein 3 is secured to distal end), wherein the elastomeric body defines a first recess that has a depth from an adjacent area of the elastomeric body, the adjacent area being proximal to the distal end, wherein the depth corresponds to a thickness of the end cap such that the end cap does not protrude beyond contours of the elastomeric body including said adjacent area (Page 8, Lines 4-12, wherein 3 has a similar shape to the corresponding outer face of 7), wherein the first recess extends distally from the adjacent area about an entirety of the distal end of the elastomeric body (Page 8, Lines 4-12, wherein 3 has a similar shape to the corresponding outer face of 7)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the prosthetic liner of Orasson with an end cap formed form an elastomeric material, as taught by McCarthy, in order to resist the slightly acidic properties of perspiration (Page 8, Line 2)
Regarding claim 7, Orrason discloses wherein the adhesive layer (Fig. 20, 374) is disposed in a pattern over the outermost surface differently from the elastomeric body (¶0115, wherein adhesive is arranged in a pattern that doesn’t occlude the ventilation feature – which corresponds to a different pattern).
Regarding claim 8, Orrason further discloses wherein the adhesive layer has a discontinuous pattern (¶0115, wherein adhesive is arranged in a pattern that doesn’t occlude the ventilation feature – which corresponds to a discontinuous pattern). disposed over the outermost surface of the elastomeric body (Fig. 20, wherein 374 is disposed over 372)
Regarding claim 9, Orrason further discloses a textile layer (Fig. 20, 314) disposed over the adhesive layer (¶0118, wherein 314 is disposed over 374), and secured to the elastomeric body by the adhesive layer (¶0118, wherein 314 is secured to 306 by 374)
Regarding claim 12, Orrason discloses wherein the tubular shape is conical (see Figs. 14 and 15, wherein 300 is conical in shape)
Regarding claim 13, Orrason discloses wherein the adhesive layer (Fig. 20, 374) is disposed in a pattern over the outermost surface (Fig. 20, 372) differently from the elastomeric body (¶0115, where “adhesive arranged not to occlude the ventilation feature of the liner” corresponds to differently that the elastomeric body) and in a discontinuous pattern relative to the axis of the body (¶0115, where the adhesive is discontinuous because it allows for the transfer of air and moisture”).
Regarding claim 14, Orrason discloses a textile layer (Fig. 20, 314) disposed over the adhesive layer (Fig. 20, wherein 314 is disposed over 374), and secured to the elastomeric body by the adhesive layer (Fig. 20, see also ¶0118, wherein 374 is secured by 314)
Regarding claim 17, Orrason discloses wherein the elastomeric body (Fig. 14, 306) defines a second recess (Fig. 15, 324) axially displaced from the first recess toward the proximal end (Fig. 14, wherein 324 located proximal to the distal end)
Regarding claim 18, Orrason further discloses wherein the second recess (Fig. 21, 324) circumferentially extends about the axis of the elastomeric body (see Fig. 21, wherein 324 extends circumferentially about axis B)
Regarding claim 19, Orrason further discloses a seal element (Fig. 21, 318) having a first portion disposed in the second recess (Fig. 21, wherein 318 is disposed in indent 324) and a second portion extending outwardly relative to the axis and beyond the outermost surface of the elastomeric body (See Fig. 18, wherein the outside of the seal extends outwardly and beyond the outermost surface of the elastomeric body)
Regarding claim 22, Orrason discloses a prosthetic liner (see rejection of claim 6) but doesn't explicitly teach or disclose wherein the first recess comprises concentric surface relief features configured to improve adherence between the first recess and the end cap.
McCarthy discloses a prosthetic liner (Fig. 1, 1) wherein the first recess (Fig. 1, 13) comprises concentric surface relief features (Fig. 1, 15 and 19) configured to improve adherence between the first recess and the end cap (¶0025, wherein “the engagement of the boss 15 in the boss recess 28 locates the sealing cap on the liner 1” corresponds to improving adherence between the first recess and the end cap.
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the prosthetic liner of Orrason with a first recess and an end cap, as taught by McCarthy, in order to prevent relative movement of the two parts (¶0035)
Regarding claim 23, The claimed phrase “wherein the end cap is integrally secured to the textile layer before the end cap is secured to the elastomeric body” is being treated as a product by process limitation; that is, that the product (a liner with an end cap, a textile layer, and an elastomeric body) is made by the process outline in claim 23. As set forth in MPEP 2113, product-by-process claims are NOT limited to the manipulations of the recited steps, only to the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 U.S.C. 103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. See MPEP 2113.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2021/0137708 A1 (Orrason) in view of WO 2018055411 (McCarthy), as applied to claims above and further in view of US 2001/0039159 (Janusson)
Regarding claim 15, Orrason discloses the textile layer (Fig. 7) has an end cap (Fig. 7, 164) but doesn’t explicitly teach or disclose an end cap formed from an elastomeric material integrated therewith. McCarthy doesn't explicitly teach or disclose an end cap formed form an elastomeric material integrated therewithin.
Janusson discloses prosthetic liner comprising: an end cap (Fig. 1, 18) formed from an elastomeric material (¶0056, wherein “silicone elastomer” corresponds to an elastomeric material”)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the textile layer of Orrason in view of McCarthy with an end cap formed from an elastomeric material, as taught by Janusson, in order to cushion the distal end of the residual limb from excessive pressure.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2021/0137708 A1 (Orrason) in view of US 2001/0039159 (Janusson) in view of US 2019/0298552 (McCarthy) in view of US 2020/0276032 (Halldorsson)
Regarding claim 20, Orrason discloses a prosthetic liner (Fig. 1, 102) comprising:
an elastomeric body (Fig. 14, 300) defined by a lattice structure (¶0030, wherein “lattice-like network” corresponds to a lattice structure) including a first layer (Fig. 3, 312) of first filaments discretely formed from a first elastomeric material (¶0077, wherein filaments 129 are formed of an elastomeric material) and overlapping a second layer of second filaments (Fig. 5D, 143b) discretely formed from a second elastomeric material (¶0087, wherein silicone corresponds to an elastomeric material), the first and second filaments of the first and second layers, respectively, overlapping and securing to one another at discrete intersections to form a first set of interstices located therebetween in a predetermined pattern (¶0099, “plurality of filaments forming a lattice structure, whereby interstices are formed between the filaments”); wherein the first and second layers are blended at least in part with one another in a blended region at an interface of the first and second layers (¶0099, wherein “forming interstices” corresponds to a blended region), the blended region forming a permanent chemical bond in which the first and second elastomeric materials of the first and second layers of the first and second filaments intermix bond (¶0035, “chemical bonding, so they are joined permanently”);
wherein the liner forms a proximal end and a distal end, and a body defined between the proximal end and distal end, and having a tubular shape defined about an axis of the body;
an adhesive layer (Fig. 20, 374) deposited on an outermost surface of the elastomeric body (Fig. 20, wherein 374 is deposited onto 372) and layered onto at least a portion of an outermost surface of the elastomeric body in a discontinuous pattern (¶0115, where the adhesive is applied discontinuously because it allows for the transfer of air and moisture”);
a textile layer (Fig. 20, 314) disposed over the adhesive layer (Fig. 20, wherein 314 is disposed over 374), and secured to the elastomeric body by the adhesive layer (Fig. 20, wherein 314 is secured to 300 via 314),
Orrason discloses a textile layer (Fig. 20, 314) having an end cap ( but doesn’t explicitly teach or disclose an end cap formed from an elastomeric material integrated with the textile layer.
Janusson discloses prosthetic liner (Fig. 1, 10) comprising: an end cap (Fig. 1, 18) formed from an elastomeric material (¶0056, wherein “silicone elastomer” corresponds to an elastomeric material”) integrated therewith (Fig. 1, ¶0034, wherein 18 is embedded with the fabric layer 14).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the textile layer of Orrason with an end cap formed from an elastomeric material, as taught by Janusson, in order to provide a cushioning and stabilizing surface at the distal end of the liner.
Orrason doesn’t explicitly teach or disclose a first recess adapted to receive the end cap such that the end cap doesn’t protrude beyond the contours of the elastomeric body. Janusson doesn’t explicitly teach or disclose a first recess adapted to receive the end cap such that the end cap doesn’t protrude beyond the contours of the elastomeric body.
McCarthy discloses a prosthetic liner (Fig. 1, 1) comprising a first recess (¶0051, wherein the “cooperating recess” corresponds to a first recess) adapted to receive the end cap (Fig. 1, 3) such that the end cap does not protrude beyond contours of the elastomeric body when secured thereon (¶0050, wherein 3 is arranged as such because it gradually tapers to meet the contours of the liner 1)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the elastomeric body of Orrason in view of Janusson with a first recess, as taught by McCarthy, in order to avoid any areas of high pressure on the residual limb.
Orrasson doesn't explicitly teach or disclose a second recess axially and a band a band disposed within the second recess, the second recess defining a surface relief configured to accommodate the band within the second recess and the second recess further defining a depth corresponding to a thickness of the band, wherein the band comprises a band material that is a different material than the elastomeric body, wherien the band material is selected form a group consisting of a textile, absorbent foam, and a substantially frictional material. Janusson doesn't explicitly teach or disclose a second recess axially and a band a band disposed within the second recess, the second recess defining a surface relief configured to accommodate the band within the second recess and the second recess further defining a depth corresponding to a thickness of the band, wherein the band comprises a band material that is a different material than the elastomeric body, wherien the band material is selected form a group consisting of a textile, absorbent foam, and a substantially frictional material. McCarthy doesn't explicitly teach or disclose a second recess axially and a band a band disposed within the second recess, the second recess defining a surface relief configured to accommodate the band within the second recess and the second recess further defining a depth corresponding to a thickness of the band, wherein the band comprises a band material that is a different material than the elastomeric body, wherien the band material is selected form a group consisting of a textile, absorbent foam, and a substantially frictional material.
Halldorsson discloses a prosthetic liner (Fig. 1) comprising an elastomeric body (Fig. 1, 12) wherein the elastomeric body further defines a second recess (Fig. 1, 16) axially displaced from the first recess toward the proximal end (see Fig. 1, wherien 16 is displaced toward the proximal end), and wherein the prosthetic liner further comprises a band (Fig. 1, seal component 14) disposed within the second recess (¶0040, “recess 16 for receiving the seal component), the second recess defining a surface relief configured to accommodate the band within the second recess and the second recess further defining a depth corresponding to a thickness of the band (¶0040, “the recess compensates for the thickness of the seal component in such a manner that the seal component does not extend or substantially extend in excess or at all beyond an exterior surface of the liner body”), wherein the band comprises a band material that is a different material than the elastomeric body (¶0034, wherein the liner is silicone, ¶0060, wherien the seal is at least rubber), wherien the band material is selected form a group consisting of a textile, absorbent foam, and a substantially frictional material (¶0060, wherein “rubber” corresponds to a substantially frictional material)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the prosthetic liner of Orasson in view of Janusson in view of McCarthy a second recess and band, as taught by Halldorsson, in order to prevent pistoning of the residual limb within the socket.
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2021/0137708 A1 (Orrason) in view of WO 2018055411 (McCarthy), as applied to claims above and further in view of US 6,231,617 (Fay)
Regarding claim 21, Orasson discloses an adhesive layer (see rejection of claim 7) but doesn't explicitly teach or disclose wherein the adhesive layer is disposed in longitudinal lines along a distal-proximal direction. McCarthy doesn't explicitly teach or disclose wherein the adhesive layer is disposed in longitudinal lines along a distal-proximal direction.
Fay discloses a prosthetic liner (Fig. 6) comprising an adhesive layer which is disposed in longitudinal lines along a distal-proximal direction (Fig. 1, 30, see also Page 7, Lines 40-50, wherien strips of epoxy are applied longitudinally the liner)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the adhesive layer of Orasson in view of McCarthy to be disposed in longitudinal lines along a distal-proximal direction, as taught by Fay, to reduce milking (i.e. undesirable axial extension of the residual limb).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
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/MAXIMILIAN TOBIAS SPENCER/Examiner, Art Unit 3774
/YASHITA SHARMA/ Primary Patent Examiner, Art Unit 3774
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