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 § 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.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 1-8 and 10-20 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.
Claims 1, 16, and 20 recite the limitation “including at least one stiffer distal portion forming a closed end and a stiffer matrix portion that extends from the at least one distal portion, the at least one distal portion and the matrix portion comprising the thermofusible yarns” (Claims 16 and 20 vary slightly in the phrase “the at least one distal portion and the matrix portion comprising the thermofusible yarns” with Claim 16 inserting a “wherein,” and both Claim 16 and Claim 20 using the form “comprise” instead of “comprising”). The limitation is indefinite as ambiguous, because it is not clear whether it means 1) there is at least one of a combination of BOTH a distal portion AND a matrix portion or 2) there is at least one of EITHER a distal portion OR a matrix portion. Additionally, it is not clear to what to compare the stiffness of either the matrix portion or the distal portion to determine whether it is “stiffer” than something else. The comparative “stiffer” is made even more problematic if the limitation is meant to be interpreted as requiring BOTH a distal portion AND a matrix portion, since it is not clear whether the second instance of “stiffer” (i.e. “stiffer matrix portion”) is meant to be compared to the stiffness as the same structure to which the “at least one stiffer distal portion” is to be compared, whether it is meant to be compared to the “at least one stiffer distal portion” which immediately precedes it, or whether it is to be compared to the stiffness of a material without features that would provide it with stiffness. As a further complication, the claim also requires that the limitation “matrix portion that extends from the at least one distal portion,” which seems to require BOTH the matrix portion AND the distal portion. Finally, it is not clear that “distal portion” has clearly defined boundaries to objectively determine whether a matrix portion extends from such distal portion or is a part of a distal portion. Thus, it is not clear a) whether both a matrix portion and distal portion are required, b) whether a matrix portion is distinct from a distal portion, or c) whether if both are required, what “stiffer” is supposed to require. Examiner considers the broadest reasonable interpretation to include a) at least one of either a distal portion that is stiffer either than another portion or a matrix portion that extends from (including that it is at least a portion of) the at least one distal portion or that one or the other or both of the distal and matrix portions are stiffer than they would be without some feature that makes them stiff (e.g. a reinforcement).
Claim 1 recites the limitation “the inner surface of the first knit structure of the textile sleeve” in lines 11-12. There is insufficient antecedent basis for this limitation in the claim. Examiner interprets the limitation to include the interpretation “an inner surface of the first knit structure of the textile sleeve” or to include the interpretation that the inner surface of the first knit structure is identical to the inner surface of the textile sleeve, since the limitation, which introduces the term “an inner surface,” is in reference to an inner surface of a textile sleeve.
Claim 5 recites the limitation "the inner surface of the textile sleeve." There is ambiguous antecedent basis for this limitation in the claim. See discussion of “inner surface” in the rejection of Claim 1 above. It is not clear whether “inner surface of the textile sleeve” is distinct from “inner surface of the first knit structure” given the definition of textile sleeve in terms of a first knit structure, inner and outer surface of the first knit structure, and the definite article in Claim 1, line 11 “the inner surface of the first knit structure of the textile sleeve” whose only preceding antecedent may be in reference to “the textile sleeve defining an inner surface and an outer surface.” Examiner considers the broadest reasonable interpretation to include that the inner surface of the textile sleeve may also be the inner surface of a first knit layer which defines, at least in part, the textile sleeve.
Claims 13 recites the limitation "the inner surface to the outer surface of the textile sleeve." There is ambiguous antecedent basis for this limitation in the claim. See rejections of Claims 1 and 5 above concerning the same issue. Examiner considers the broadest reasonable interpretation to include that the inner surface and the outer surface of the textile sleeve may also be the inner surface and the outer surface of a first knit layer which defines, at least in part, the textile sleeve.
Claim 13 recites the limitation “is arranged for the silicone material to extend through the second knit structure from the inner surface to the outer surface of the textile sleeve.” The limitation is indefinite, because it is not clear what is meant by the second knit structure being arranged for the silicone material to extend through the second knit structure specifically to the outer surface of the textile sleeve, where Claim 1, from which Claim 13 depends, specifically constrains silicone material to the inner surface of the textile sleeve (which may also be the inner surface of the first knit structure, which defines the textile sleeve in Claim 1) and prohibits silicone material from the outer surface of the textile sleeve. Examiner considers the claim to improperly depend from Claim 1, since it does not include the constraints (which dependency required) from Claim 1.
Claim 13 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 13 recites the limitation the second knit structure “is arranged for the silicone material to extend through the second knit structure from the inner surface to the outer surface of the textile sleeve.” Claim 1, from which Claim 13, does not permit the silicone to extend through the second knit structure from the inner surface to the outer surface of the textile sleeve (defined by first knit structure in Claim 1), since it expressly constrains the silicone to the inner surface of the textile sleeve.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1,5-7, 10, and 14-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Janusson et al. (US 2001/0039159) in view of Pickering et al. (US 2007/0043450) and Jackson et al. (US 2005/0282453).
Regarding Claim 1, Janusson et al. (US’159) teach a liner for prosthetic use, the liner having an exterior surface and an inner cavity forming an interior surface of the liner, the liner defining proximal and distal ends along a central longitudinal axis, the liner comprising: a textile sleeve 14 having a first knit structure with interstices (a feature of knitted yarns) between yarns of said first knit structure, the textile sleeve defining an inner surface and an outer surface on an opposite side of the inner surface (Figs. 1,6,7; [0022,0054]); a silicone material provided on the inner surface of the textile sleeve and impregnating the interstices of the first knit structure of the textile sleeve (a coated silicone elastomer layer 24, which partially penetrates, is embedded in the fabric layer and cured while embedded in textile which renders the knit textile and silicone layer 24 impermeable to air) [0054], wherein the silicone material impregnates only the inner surface of the textile sleeve (partially penetrates and is embedded [0021] while not completely penetrating the fabric layer [0037] (i.e. the outer surface is devoid of the silicone material) [0037].
US’159 teaches that the textile sleeve includes at least one distal portion forming a closed end and a matrix portion (comprising knit fabric) extending from the at least one distal portion (Figs 1-2; [0010,0012]). US’159 fails to teach that the matrix portion comprises specifically thermofusible yarns. It is obvious to use thermofusible yarns to prevent fraying and unraveling of knit fabric (See rejection of Claim 1 above). It would have been obvious to include thermofusible yarns as desired in the knitted matrix portion, because US’450 suggests incorporating thermofusible yarns in knitted fabric to stop fraying and unraveling of knit fabric. Additionally, US’159 teaches that the distal end, in particular, includes a reinforcement matrix extending from it, that is that the distal end and its matrix are stiffer than they would be otherwise, because of additional reinforcement to provide substantial stiffness [0012].
US’159 fails to teach the textile sleeve having at least one region having thermofusible yarns arranged such as to fuse upon reaching a threshold temperature. Pickering et al. (US’450) is analogous prior art in the field of knitted prosthetic liners (socks) (Abstract; Fig. 1), and suggests a thermofusible yarn, capable of fusing to prevent fraying and unraveling where fused [0047]. It would have been obvious to a person of ordinary skill in the art at the time of invention to modify the prosthetic liner of US’159 with thermofusible yarns, because US’450 suggests that thermofusible yarn can prevent fraying and unraveling.
US’159 teaches a silicone elastomer (Abstract). The combination of US’159 in view of US’450 fails to teach a silicone material (e.g. polysiloxane), curable to at least 90% crosslinking within a range of about 120 to 210 seconds. Quick curing silicone material (polysiloxane) was well-known in the prior art at the time of invention and could be cured (crosslinked) within seconds to minutes, whether by UV curing (e.g. 2-5 seconds) or by thermal curing within minutes (e.g. 2-5 minutes). For example, Jackson et al. (US’453) is analogous art in the field of silicone elastomer coatings for fabric, including knits [0199,0058-0061,0114], and teaches curing times of between 15 and 240 seconds (four minutes) [0206]. In addition, US’159 suggests that curing time and temperature are easily optimized based on composition and coating thickness including motivations to cure more slowly as desired (e.g. to allow more penetration) [0206]. It would have been obvious to a person of ordinary skill in the art at the time of invention to modify the liner of the combination of US’159 in view of US’450 with a silicone material having the recited curing properties through routine optimization. Moreover, process limitations (e.g. curing or crosslinking) are not given patentable weight for the claimed product.
NOTE: because the claim is directed to a product, not to a process, the limitation “pre-formed configuration” is not given significant patentable weight, because it does not substantially add any additional structural definition, but merely suggests a step in a process for making.
Regarding Claim 5, US’159 teaches that the silicone material forms an inner layer of the liner, the inner layer forms the interior surface of the liner and the outer surface of the textile sleeve forms the exterior surface of the liner, wherein a thickness of the liner from the interior surface of the liner to the inner surface of the textile sleeve consists of the silicone material of the inner layer (Fig. 1; [0021,0037,0054]).
Regarding Claims 6-7, US’159 teaches a jersey knit (Claim 16).
Regarding Claim 10, US’159 teaches optional reinforcement fibers 26, including in the form of matrix, which extends over a distal portion of the liner (Fig. 1; [0038,0040,0053]) and which is a portion of a larger structure 12, including a body portion which extends from the matrix to a proximal end forming an open end of the textile sleeve (Figure 1; [0034]). Except for the matrix 26, the body portion comprises a composite elastic material, comprising silicone elastomer [0039]. Thus, because the body portion is primarily silicone elastomer, it would have been obvious that it would be devoid of thermofusible yarn.
Regarding Claim 14, US’159 teaches that the textile sleeve defines at least one more knit structure connected to the first knit structure, the at least one more knit structure having a different knit structure than the first knit structure including different axial or radial elongation (circular knit textile) [0012,0038,0053].
Regarding Claim 15, US’159 teaches that the silicone 24 forms an entirety of the interior surface of the inner cavity of the liner (Fig. 1; [0054]).
Regarding Claim 16, US’159 teaches a liner for prosthetic use, the liner having an exterior surface and an inner cavity forming an interior surface of the liner, the liner defining proximal and distal ends along a central longitudinal axis, the liner comprising: a textile sleeve having a first knit structure with interstices (a feature of knitted yarns) between yarns of said first knit structure, the textile sleeve defining an inner surface and an outer surface on an opposite side of the inner surface (Figs. 1,6,7; [0022,0054]); a silicone material provided on the inner surface of the textile sleeve and impregnating the interstices of the first knit structure of the textile sleeve; wherein the silicone material impregnates the inner surface of the textile sleeve (a coated silicone elastomer layer 24, which partially penetrates, is embedded in the fabric layer and cured while embedded in textile which renders the knit textile and silicone layer 24 impermeable to air) [0054]; wherein the textile sleeve includes at least one distal portion forming a closed end and a matrix portion extending from the at least one distal portion (Figs 1-2; [0010,0012]). Additionally, US’159 teaches that the distal end, in particular, includes a reinforcement matrix extending from it, that is that the distal end and its matrix are stiffer than they would be otherwise, because of additional reinforcement to provide substantial stiffness [0012].
US’159 fails to teach thermofusible yarns. Pickering et al. (US’450) is analogous prior art in the field of knitted prosthetic liners (socks) (Abstract; Fig. 1), and suggests a thermofusible yarn, capable of fusing to prevent fraying and unraveling where fused [0047]. It would have been obvious to a person of ordinary skill in the art at the time of invention to modify the prosthetic liner of US’159 with thermofusible yarns in the knitted matrix and/ or distal portion, because US’450 suggests that thermofusible yarn can prevent fraying and unraveling.
NOTE: because the claim is directed to a product, not to a process, the limitation “pre-formed configuration” is not given significant patentable weight, because it does not substantially add any additional structural definition, but merely suggests a step in a process for making, not given patentable weight.
Claim(s) 2 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Janusson et al. (US 2001/0039159) in view of Pickering et al. (US 2007/0043450) and Jackson et al. (US 2005/0282453) as applied to Claims 1 and 16 above, and further in view of Richardson et al. (US 6,071,578).
Regarding Claims 2 and 17, US’450 teaches a thermofusible yarn, but fails to teach a specific temperature range for melting and fusing. Richardson et al. (US’578) is analogous art, pertinent to the inventor’s problem of using thermofusible yarn in knit fabric and suggests a thermofusible yarn capable of fusing at a temperature of about 85 C, the yarn’s melting temperature (col. 1, lines 43-50; col. 2, lines 11-19). It would have been obvious to a person of ordinary skill in the art at the time of invention to modify the prosthetic liner of the combination of US’159 in view of US’450 and US’453 with a thermofusible yarn, capable of fusing at 85 C, because US’578 suggests the availability of such yarns for knitting.
Claim(s) 3 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Janusson et al. (US 2001/0039159) in view of Pickering et al. (US 2007/0043450) and Jackson et al. (US 2005/0282453) as applied to Claims 1 and 16 above, and further in view of Bazoud et al. (US 2017/0071794).
Regarding Claims 3 and 18, US’450 teaches a thermofusible yarn, but fails to teach a specific temperature range for melting and fusing. Bazoud et al. (US’794) is analogous art, pertinent to inventor’s problem of using thermofusible yarn in knit fabric (Abstract) and suggests a thermofusible yarn with a melting temperature of 125 C [0057]. It would have been obvious to a person of ordinary skill in the art at the time of invention to modify the prosthetic liner of the combination of US’159 in view of US’450 and US’453 with a thermofusible yarn, capable of fusing at a temperature in the range of 110-150C, because US’578 suggests the availability of such yarns for knitting.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Janusson et al. (US 2001/0039159) in view of Pickering et al. (US 2007/0043450) and Jackson et al. (US 2005/0282453) as applied to Claim 1 above, and further in view of Bache et al. (US 2017/0027719).
Regarding Claim 4, the combination of US’159 in view of US’450 and US’453 fails to teach a seam. Seams were conventionally used to join sections of fabric, including knitted fabric at the time of invention, although US’450 also provides reasons not to use conventional seams [0005]; on the other hand, US’453 suggests seams [0227]. The combination of US’159 in view of US’450 and US’453 fails to teach a seam located specifically at a distal end of the textile sleeve. Bache et al. (US’719) is analogous art in the field of knitted prosthetic liners (Abstract; (Fig. 1A), and suggests a liner with a seam 3 at a distal end of the textile sleeve (Fig. 1; [0033]). It would have been obvious to a person of ordinary skill in the art at the time of invention to provide a seam at a distal end of the textile sleeve, because US’719, analogous art, suggests a seam used to close or finish a knitted textile sleeve at a distal end of a prosthetic liner. US’450 teaches thermofusible yarn to stop fraying and unraveling. It would have been obvious to a person of ordinary skill in the art at the time of invention to modify the prosthetic liner of the combination of references by providing thermofusible yarn at the seam to stop fraying and unraveling, especially since one would expect a knitted fabric to be vulnerable to fraying and/ or unraveling specifically at a seam.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Janusson et al. (US 2001/0039159) in view of Pickering et al. (US 2007/0043450) and Jackson et al. (US 2005/0282453) as applied to Claim 5 above, and further in view of Doddroe et al. (US 2011/0208321).
Regarding Claim 8, the combination of US’159 in view of US’450 and US’453 fails to teach that the first knit structure includes a taslanized or air-textured yarn. Doddroe et al. (US’321) is analogous art in the field of knitted prosthetic liners (Abstract; Fig. 2) and suggest that a taslan nylon yarn is suitable as a yarn for the knitted liner [0044]. It would have been obvious to a person of ordinary skill in the art at the time of invention to modify the prosthetic liner suggested by the combination of US’159 in view of US’450 and US’453 with a taslanized yarn, because US’321 suggests Taslan yarn is a suitable yarn for a knitted prosthetic liner.
Claim(s) 11-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Janusson et al. (US 2001/0039159) in view of Pickering et al. (US 2007/0043450), and Jackson et al. (US 2005/0282453), as applied to Claim 10 above, and further in view of Laghi et al. (US 2013/0331950).
Regarding Claim 11, US’159 teaches a second knit structure, including a knitted circular knit textile as a reinforcement matrix [0012]. The combination of US’159 in view of US’450, and US’453 fails to teach that the textile sleeve further comprises a second knit structure comprising a coarser knit than the first knit structure. Laghi et al. (US’950) is analogous art in the field of prosthetic liners (Abstract; Fig. 3) and teaches an intermediate portion (7) just above the distal portion of the liner [0017], and provides evidence that stitch count (i.e. “coarser” or “finer”) and yarn type are result effective variables, known in the art at the time of invention to affect stiffness of the knit fabric and the extent to which a fluid (e.g. melt from meltable fiber) can flow through the fabric [0017]. Thus, it would have been obvious to a person of ordinary skill in the art at the time of invention to modify the second knit structure of the prosthetic liner of the combination of US’159 in view of US’450, and US’453 with a coarser knit than the first knit through routine optimization with a reasonable expectation of achieving a desired degree of impregnation of silicone material and/or a desired degree of stiffness of the reinforcing second knit structure of US’159.
Regarding Claim 12, US’159 teaches a second knit structure, including a knitted circular knit textile as a reinforcement matrix [0012]. US’159 fails to teach that the second knit structure defines a plurality of circumferential bands. However, a plurality of circumferential bands of the knitted circular knit matrix is a prima facie obvious duplication of parts (MPEP 2144.04), and it would have been obvious to include as many circumferential bands as reinforcement matrices as need to provide the prosthetic liner with a desired degree of reinforcement and/ or stiffness.
Regarding 13, US’159 teaches that the second knit structure comprises an inelastic knit structure [0012] and is arranged so that the circular knit textile reinforcement matrix is embedded in the silicone elastomer. For the reasons provided in the rejection of Claim 1 above, it would have been obvious for the silicone material to extend through the second knit structure from the inner surface to the outer surface of the textile sleeve.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Janusson et al. (US 2001/0039159) in view of Pickering et al. (US 2007/0043450) and Jackson et al. (US 2005/0282453) as applied to Claim 16 above, and further in view of Egilsson et al. (US 2007/0123998).
Regarding Claim 19, US’159 teaches that the silicone material forms an inner layer of the liner, the inner layer forms the interior surface of the liner and the outer surface of the textile sleeve forms the exterior surface of the liner, wherein a thickness of the liner from the interior surface of the liner to the inner surface of the textile sleeve consists of the silicone material of the inner layer (Fig. 1; [0021,0037,0054] and that the first knit structure is selected from the group consisting of jersey and pique (Claim 16). US’159 teaches that the second knit structure comprises an inelastic knit structure [0012] and is arranged so that the circular knit textile reinforcement matrix is embedded in the silicone elastomer. For the reasons provided in the rejection of Claim 1 above, it would have been obvious for the silicone material to extend through the second knit structure from the inner surface to the outer surface of the textile sleeve.
The combination of US’159 in view of US’450 and US’453 fails to teach that the silicone material bleeds through an entirety of a thickness of the textile sleeve and defines silicone seal-in bands along the exterior surface of the liner. Egilsson et al. (US 2007/0123998) is analogous art in the field of prosthetic liners and suggests that silicone seal elements that protrude from the liner sleeve and that provide a seal between a liner sleeve and a socket may be formed integrally with the silicone inner layer of the liner sleeve [0014,0018,0023,0059]. It would have been obvious to a person of ordinary skill in the art at the time of invention to modify the combination of US’159 in view of US’450 and US’453 with silicone material which bleeds through an entirety of a thickness of the textile sleeve, including through the inelastic bands of reinforcement inelastic textile and defines silicone seal-in bands along the exterior surface of the liner, because US’998 suggests bands of seal elements formed integrally with silicone formed on an inner layer of the liner to form a seal between liner sleeve and socket.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Janusson et al. (US 2001/0039159) in view of Pickering et al. (US 2007/0043450).
Regarding Claim 20, US’159 teaches a liner for prosthetic use, the liner having an exterior surface and an inner cavity forming an interior surface of the liner, the liner defining proximal and distal ends along a central longitudinal axis, the liner comprising: a textile sleeve having a first knit structure with interstices (a feature of knitted yarns) between yarns of said first knit structure, the textile sleeve defining an inner surface and an outer surface on an opposite side of the inner surface (Figs. 1,6,7; [0022,0054]); a silicone material provided on the inner surface of the textile sleeve and impregnating the interstices of the first knit structure of the textile sleeve; wherein the silicone material impregnates the inner surface of the textile sleeve (a coated silicone elastomer layer 24, which partially penetrates, is embedded in the fabric layer and cured while embedded in textile which renders the knit textile and silicone layer 24 impermeable to air) [0054],wherein the silicone material forms an inner layer of the liner, the inner layer forms the interior surface of the liner and the outer surface of the textile sleeve forms the exterior surface of the liner, wherein a thickness of the liner from the interior surface of the liner to the inner surface of the textile sleeve consists of the silicone material of the inner layer (Fig. 1; [0021,0037,0054]) and wherein the textile sleeve includes at least one distal portion forming a closed end and a matrix portion extending from the at least one distal portion (Figs 1-2; [0010,0012]). Additionally, US’159 teaches that the distal end, in particular, includes a reinforcement matrix extending from it, that is that the distal end and its matrix are stiffer than they would be otherwise, because of additional reinforcement to provide substantial stiffness [0012].
US’159 fails to teach thermofusible yarns. Pickering et al. (US’450) is analogous prior art in the field of knitted prosthetic liners (socks) (Abstract; Fig. 1), and suggests a thermofusible yarn, capable of fusing to prevent fraying and unraveling where fused [0047]. It would have been obvious to a person of ordinary skill in the art at the time of invention to modify the prosthetic liner of US’159 with thermofusible yarns in the knitted matrix and/ or distal portion, because US’450 suggests that thermofusible yarn can prevent fraying and unraveling.
NOTE: because the claim is directed to a product, not to a process, the limitation “pre-formed configuration” is not given significant patentable weight, because it does not substantially add any additional structural definition, but merely suggests a step in a process of making, not given patentable weight.
Response to Arguments
Applicant's arguments filed 23 June 2026 have been fully considered but they are not persuasive.
In response to Applicant’s argument that the amendment to the claims overcomes the rejection of Claim 13 under 35 USC 112(b) (Remarks, p. 10), the amendment to the claims raised further issues under 35 USC 112(b). See rejections under 35 USC 112 above.
In response to Applicant’s argument concerning “pre-formed textile sleeve” (Remarks, p. 11), the argument is not persuasive, because it recites a history of production rather than further constraining structure. Because the claims are drawn to a product, not to a process of making, the limitation is not given significant patentable weight.
In response to Applicant’s argument, attempting to associate the process language “pre-formed” with certain structural characteristics (Remarks, p. 11), Applicant has not made a sufficient showing that the structures of Janusson could not be “pre-formed” in some way.
In response to Applicant’s argument that an elasticized textile layer 14 of Janusson would not be equivalent to a textile sleeve that has a pre-formed configuration including at least one stiffer distal portion forming a closed end and a stiffer matrix portion that extends from the at least one distal portion, the at least one distal portion and the matrix portion comprising thermofusible yarns (Remarks, p. 12), the argument is not persuasive, because Janusson teaches that the distal end can include reinforcements matrix which can provide substantial stiffness [0012], and Applicant has provided no clear reason to think that these structures preclude the distal end having some “pre-formed configuration,” which is both broad and not particularly significant for patentability of the product. Instead, Applicant argues that Janusson’s describes steps in a process of making. However, the argument is not persuasive, because whether Janusson teaches a different process is not particularly relevant to the structural features of the product claims.
In response to Applicant’s argument concerning Pickering (Remarks, pp. 12-13), Pickering suggests to a person more broadly than Applicant’s reading to use thermofusible yarn wherever needed to prevent fraying and unraveling where fused. Moreover, it is precisely at ends of a structure (or even at ends where changing yarns or threads anywhere during knitting) where one can most expect fraying.
Conclusion
No claim is allowed.
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDER M WEDDLE whose telephone number is (571)270-5346. The examiner can normally be reached 9:30-6:30.
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ALEXANDER M WEDDLE
Examiner
Art Unit 1712
/ALEXANDER M WEDDLE/Primary Examiner, Art Unit 1712
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