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 .
The first inventor to file provisions of the Leahy-Smith America Invents Act (AIA ) apply to any application for patent, and to any patent issuing thereon, that contains or contained at any time—
(A) a claim to a claimed invention that has an effective filing date on or after March 16, 2013 wherein the effective filing date is:
(i) if subparagraph (ii) does not apply, the actual filing date of the patent or the application for the patent containing a claim to the invention; or
(ii) the filing date of the earliest application for which the patent or application is entitled, as to such invention, to a right of priority under 35 U.S.C. 119, 365(a), or 365(b) or to the benefit of an earlier filing date under 35 U.S.C. 120, 121, or 365(c); or
(B) a specific reference under 35 U.S.C. 120 , 121, or 365(c), to any patent or application that contains or contained at any time a claim as defined in paragraph (A), above.
Status of the Claims
Claim(s) 1-5, 7, 9, 11-16, 18, and 20 is/are pending. Claim(s) 6, 8, 10, 17, and 19 are is/are canceled.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/4/2026 has been entered.
Response to Arguments
Applicant's arguments filed 2/4/2026 have been fully considered but they are not persuasive.
Applicant argues Laghi and Doddroe do not teach "the prosthesis liner has a distal cap with at least one fastening element for fastening the prosthesis liner to the prosthesis socket, where the distal ends of the at least one tension element is bonded to the distal cap" (Applicant's Response on 2/4/2026, herein "Response", page 13).
This language is taught by the combination of the prior art as detailed below in the prior art rejection section.
Applicant argues Doddroe does not teach "the elastic cord disclosed in paragraphs [0039] and [0040] of Doddroe correspond to the claimed tension element and that paragraph [0061] of Doddroe discloses the distal ends of the elastic cords are bonded to the docking element 50" (Response, page 13).
This language is taught by the combination of the prior art as detailed below in the prior art rejection section.
Applicant argues [0039] and [0040] only teach the "elastic cord may be inserted (laid-in) every course, or every 2, 3, or 4 courses, etc" and [0061] only discusses umbrella portion 70 and does not describe elastic cords. Laghi describes stitch types in its Figures 6A-6N and the loops are not necessarily at the distal ends. (Response, pages 13-14). Applicant argues "none of the cited references describe or suggest two ends of the tension element are bonded to the distal cap and loops at the proximal ends of the tension elements as recited in independent claims 1, 14, and 20" (Response, page 14).
This language is taught by the combination of the prior art as detailed below in the prior art rejection section. Specifically, this limitation is taught by Doddroe in [0033], [0036] along with [00396]-[0040] and [0060]-[0061].
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2 and 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.
Claim 2 recites “preferably”. It is unclear if the language following “preferably” is required or merely preferred (i.e. not necessary/required).
Claim 20, line 18 recites “a distal cap”. It is unclear if this is the same or a different distal cap than that introduced earlier in line 9. For purposes of examination the Examiner considers this language to be “the distal cap”.
Claim 20, lines 18-19 recites “at least one fastening element”. It is unclear if this is the same or a different at least one fastening element introduced in line 9.
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.
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 1-5, 7, 9, 11-16, 18, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Doddroe, et al (Doddroe) (EP 2538892 B1) in view of Mosler, et al (Mosler) (WO 2014/032815 A1) and further in view of Laghi, et al (Laghi) (US 2019/0070024 A1).
Regarding Claim 1, Doddroe teaches a prosthesis liner (e.g. Figures 1-2, 7; [0022], Fig 7 caption) comprising:
a base body (#35) made of an elastic liner material (e.g. [0045]-[0046]) which comprises an open proximal end (e.g. [0024]), a closed distal end opposite the open proximal end (e.g. [0024]), and a longitudinal extension (e.g. Figures 1-2, 7), which extends from the open proximal end to the closed distal end (e.g. Figures 1-2, 7);
a bi-elastic textile layer (#20, 25, e.g. [0029], [0036]-[0037]) arranged on or in the elastic liner material (e.g. Figure 2), and
a connection region (e.g. Figure 1a, #50) that is arranged and configured to be connected to a prosthesis socket (e.g. [0018], [0057]);
wherein the bi-elastic textile layer has, in a section that extends proximally from the connection region, at least one tension element incorporated into the bi-elastic textile layer (e.g. [0039]-[0040], elastic cords of section #20 and [0033], [0036], two-way stretch fabric of #25 having stretch fibers and cords therein) by means of which the elasticity of the bi-elastic textile layer in the longitudinal extension of the base body is reduced (e.g. [0039], the modulus is lowered and thus the elasticity is reduced), wherein the prosthesis liner has a distal cap (e.g. Figures 7-8, #50) with at least one fastening element for fastening the prosthesis liner to the prosthesis socket (e.g. #65, [0060]), and the distal ends of the at least one tension element [are] bonded to the distal cap (e.g. [0060]-[0061], two fiber/cord ends located under where #50 bonds to the fabric meet this requirement).
Doddroe discloses the invention substantially as claimed but fails to teach the at least one tension element comprises fibers and/or threads made of an inelastic material having two ends.
Mosler teaches a prosthesis liner having fibers (which inherently have two ends) in a layer that are made of an inelastic material (e.g. abstract).
Mosler and Doddroe are concerned with the same field of endeavor as the claimed invention, namely prosthesis liners having layers with fibers.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Doddroe by incorporating the inelastic fibers of Mosler in order to adjust the fabric to the optimal performance and comfort (e.g. Doddroe, [0039]).
The combination of Doddroe and Mosler teaches discloses the invention substantially as claimed but fails to teach at least one tension element forms a loop at its proximal end, which is guided around at least one of the threads of the bi-elastic textile layer.
Laghi teaches fibers used in the prosthesis liner that forms a loop at their proximal end (e.g. Figures 6A-B, [0033]).
Laghi and the combination of Doddroe and Mosler are concerned with the same field of endeavor as the claimed invention, namely prosthesis liners.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Doddroe and Mosler by incorporating the looped shape for the fibers as taught by Laghi as such a modification would have been an obvious matter of design choice involving a change in the shape of a component. A change in shape is generally recognized as being within the level of ordinary skill in the art, In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) (The court held that the configuration of the claimed disposable plastic nursing container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant.) (see MPEP 2144.04(IV)(B)).
The combination of Doddroe, Mosler, and Laghi teaches the loops guided around at least one of the threads of the textile layer (e.g. Doddroe, [0039], at least because the fiber is within the textile layer).
The combination of Doddroe, Mosler, and Laghi discloses the invention substantially as claimed but fails to teach.
Regarding Claim 2, the section preferably extends from the closed distal end (e.g. Doddroe, Figure 2), wherein the connection region is formed by the distal cap (e.g. Doddroe, Figures 7-8, #50) with at least one fastening element for fastening the prosthesis liner to the prosthesis socket (e.g. Doddroe, #65, [0060]).
Regarding Claim 3, the connection region is limited proximally by at least one sealing lip (e.g. Doddroe, Figure 7, #70).
Regarding Claim 4, the at least one tension element extends into the connection region (e.g. Doddroe, annotated Figure 7 below, where the connection region is below the added line) and/or wherein the bi-elastic textile layer also features the at least one tension element in the connection region as well, by way of which the elasticity of the bi-elastic textile layer is reduced in the longitudinal extension of the base body (this option is not required due to the preceding “or").
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Annotated Figure 7, Doddroe
Regarding Claim 5, the at least one tension element comprises a plurality of tension elements and the plurality of tension elements is distributed equidistantly across a circumference of the bi-elastic textile layer (e.g. Doddroe, [0039]).
Regarding Claim 7, the plurality of tension elements is fastened at their open proximal end, which is located at a distance from the open proximal end of the base body, to the bi-elastic textile layer in such a way that tension forces acting on the plurality of tension elements in the longitudinal extension are transmitted to the bi-elastic textile layer (e.g. Doddroe, [0041]).
Regarding Claim 9, the at least one tension element extends at least into the section of the bi-elastic textile layer (discussed supra for claim 4).
Regarding Claim 11, the distal cap is integrated into the prosthesis liner (e.g. Doddroe, Figure 7, [0061]).
Regarding Claim 12, the prosthesis liner is designed to enclose a joint of an amputation stump when in a mounted state, with the section terminating distally of the joint (e.g. [0001]).
Regarding Claim 13, the combination of Doddroe and Mosler teaches a system composed of a prosthesis liner according to claim 1 (discussed supra for claim 1), wherein the prosthesis socket is designed in such a way that it can be connected to the connection region of the prosthesis liner (e.g. Doddroe, [0065]).
Regarding Claim 14, the combination of Doddroe and Mosler teaches a prosthesis liner (discussed supra for claim 1) comprising:
a base body made of an elastic liner material (discussed supra for claim 1), the base body comprising:
an open proximal end, a closed distal end opposite the open proximal end,
a longitudinal extension which extends from the open proximal end to the closed distal end (discussed supra for claim 1);
a bi-elastic textile layer arranged on or in the elastic liner material (discussed supra for claim 1); and
a connection region configured to be connected to a prosthesis socket (discussed supra for claim 1);
wherein the bi-elastic textile layer has at least one tension element incorporated into the bi-elastic textile layer in a section that extends proximally from the connection region, the at least one tension element configured to reduce an elasticity of the bi-elastic textile layer in the longitudinal extension of the base body (discussed supra for claim 1); and
wherein the at least one tension element is positioned in the connection region (discussed supra for claim 4), the at least one tension element configured to reduce the elasticity of the bi-elastic textile layer in the longitudinal extension of the base body (discussed supra for claim 1), and
wherein the at least one tension element comprises fibers and/or threads made of an inelastic material having two ends (discussed supra for claim 1), wherein the at least one tension element forms a loop at its proximal end (discussed supra for claim 1), which is guided around at least one thread of the bi-elastic textile layer (discussed supra for claim 1), wherein the prosthesis liner has a distal cap with at least one fastening element for fastening the prosthesis liner to the prosthesis socket (discussed supra for claim 1), and wherein the two ends of the at least one tension element are bonded to the distal cap (discussed supra for claim 1).
Regarding Claim 15, the at least one tension element comprises a plurality of tension elements and the plurality of tension elements is distributed across a circumference of the bi-elastic textile layer (discussed supra for claim 5).
Regarding Claim 16, the plurality of tension elements is distributed equidistantly across the circumference of the bi-elastic textile layer (e.g. Doddroe, [0039]).
Regarding Claim 18, the plurality of tension elements is fastened at their open proximal end and is located at a distance from the open proximal end of the base body, to the bi-elastic textile layer in such a way that tension forces acting on the plurality of tension elements in the longitudinal extension are transmitted to the bi-elastic textile layer (discussed supra for claim 7).
Regarding Claim 20, the combination of Doddroe and Mosler teaches a prosthesis liner (discussed supra for claim 1) comprising:
a base body made of an elastic liner material (discussed supra for claim 1), the base body comprising: an open proximal end, a closed distal end opposite the open proximal end, a longitudinal extension which extends from the proximal end to the distal end (discussed supra for claim 1);
a bi-elastic textile layer arranged on or in the elastic liner material (discussed supra for claim 1);
a connection region configured to be connected to a prosthesis socket (discussed supra for claim 1); and
a distal cap with at least one fastening element for fastening the prosthesis liner to a prosthesis socket (discussed supra for claim 2);
wherein the bi-elastic textile layer has a plurality of tension elements incorporated into the bi-elastic textile layer and distributed across a circumference of the bi-elastic textile layer and extending proximally from the connection region (discussed supra for claims 1, 5), the plurality of tension elements comprising fibers and/or threads of an inelastic material having two ends (discussed supra for claim 1), the plurality of tension elements being configured to reduce an elasticity of the bi-elastic textile layer in the longitudinal extension of the base body (discussed supra for claim 1), wherein the plurality of tension elements forms a loop at its proximal end (discussed supra for claim 1), which is guided around at least one thread of the bi-elastic textile layer (discussed supra for claim 1), wherein the prosthesis liner has a distal cap with at least one fastening element for fastening the prosthesis liner to the prosthesis socket (discussed supra for claim 1), and wherein the two ends of the at least one tension element are bonded to the distal cap (discussed supra for claim 1)..
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LESLIE A LOPEZ whose telephone number is (571)270-7044. The examiner can normally be reached 8:30 AM - 5:30 PM, MST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, THOMAS BARRETT can be reached at (571)272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LESLIE A LOPEZ/Primary Examiner, Art Unit 3774 4/30/2026
