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 .
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 5/21/2026 is acknowledged. Claim 17-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/21/2026. The requirement is deemed proper and is therefore made FINAL.
Claim Objections
Claim 5 is objected to because of the following informalities: a misplaced parenthesis in line 3. Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-4, 14, and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kurth (Pub. No.: US 2017/0304085 A1).
Kurth discloses the following regarding claim 1: a brim for securing to a proximal end of a prosthetic rigid socket (Fig. 2), the socket (50) (paras. 0029-0031) defining an opening at the proximal end (Fig. 2), and outer (exterior surfaces of element 50) and inner (interior surfaces of element 50) surfaces, the brim being coaxial to a central axis (113) of the socket (Fig. 2), the brim comprising: a cuff section (upper portion of element 100) arranged to flexibly extend about and upwardly or proximally from a peripheral proximal end of the socket (Fig. 2; paras. 0028-0029); an interface section (lower portion of element 100) defining a lower or distal portion of the brim extending distally from the cuff section (Fig. 2), the interface section adhering to the inner surface of the socket (paras. 0029-0040); a reinforcement layer (114) corresponding at least with the interface section (Fig. 2; para. 0029).
Kurth discloses the following regarding claim 2: the brim of claim 1, wherein the reinforcement layer extends across a transition section (central portion of element 100) extending from the interface section to the cuff section (Fig. 2; para. 0029).
Kurth discloses the following regarding claim 3: the brim of claim 1, wherein an inner surface of the brim is continuous and smoothly transitions from the cuff section to the interface section across the transition section without interruption and variation in contour (Fig. 2).
Kurth discloses the following regarding claim 4: the brim of claim 1, wherein the reinforcement layer is formed from a textile having less elasticity from a material forming the cuff section (para. 0029).
Kurth discloses the following regarding claim 14: the brim of claim 1, wherein the interface section secures to the inner surface of the socket (Fig. 2; paras. 0029-0040).
Kurth discloses the following regarding claim 15: the brim of claim 1, further comprising a supplementary layer (116) located about or along an outer surface of the interface section (Fig. 2).
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) 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kurth in view of Egilsson (US Pat. No.: 7,025,793).
Kurth discloses the limitations of the claimed invention, as described above. It further recites a transition section (central section of element 100) defined between the cuff section and the interface section (Fig. 2). However, it does not recite the transition section defining an indent about at least a segment of an outer periphery of the brim. Egilsson teaches that it is well known in the art that a central portion of a brim comprises an indent about its outer periphery (e.g., 10, 28); and the indent is defined as a reduction of wall thickness from the cuff section to the interface section along an outer surface of the brim (Figs. 4-20; col. 6, lines 15-43; col. 7, lines 50-col. 8, lines 16). This configuration improves the cooperation and the security of the connection between the brim and the prosthesis. It would have been an obvious matter of design choice to one having ordinary skill in the art to modify the device of Kurth to comprise an indent, as taught by Egilsson, in order to improve the cooperation and the security of the connection between the brim and the prosthesis. Such a modification would be made with a reasonable expectation of success.
Claim(s) 7-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kurth in view of Egilsson, further in view of Egilsson et al. (US Pat. No.: 9,474,635; hereinafter “the ‘635 reference”).
Regarding claims 7 and 9-10, Kurth, as modified by Egilsson, teaches the limitations of the claimed invention, as described above. However, they do not explicitly recite the brim having the claimed the heights and thicknesses. The ‘635 reference teaches that it is well known in the art that a thickness of the cuff section increases toward a proximal circumferential edge (Figs. 1B, from the lower, central portion to the proximal portion; col. 7, lines 14-32). The ‘635 reference also teaches a segment about a circumference of the cuff section on a first or lateral side of the brim has a greater height from the transition section to the proximal circumferential edge than a height of another segment of the cuff section on a second or medial side of the brim (Figs. 1A-1B, 5). The upper, cuff section has a greater wall thickness between the outer and inner surfaces at the second or medial side of the brim than a wall thickness at the first or lateral side of the brim (Figs. 2A-2B, 5-7). This configuration provides the brim and the cuff with the desired sizes and dimensions needed to properly support and fit a particular patient. It would have been an obvious matter of design choice to one having ordinary skill in the art to modify the device of Kurth and Egilsson to comprise the claimed dimensions, as taught by the ‘635 reference, in order provide the brim and the cuff with the desired sizes and dimensions needed to properly support and fit a particular patient. Such a modification would be made with a reasonable expectation of success. In addition, the optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for one of ordinary skill to determine the optimal thickness, heights, and dimensions needed to achieve the desired results and properly fit a patient. Thus, absent some demonstration of unexpected results from the claimed parameters, the optimization of the thickness, heights, and dimensions, would have been obvious at the time of applicant's invention in view of the teachings of the prior art. It is well-established that merely selecting proportions and ranges is not patentable absent a showing of criticality. In re Becket, 33 USPQ 33; In re Russell, 169 USPQ 426.
Kurth teaches the following regarding claim 8: the brim of claim 7, wherein a thickness of the interface section decreases toward a distal circumferential edge (at element 116) (Figs. 2-3).
Kurth teaches the following regarding claim 11: the brim of claim 9, wherein the interface section has a uniform height from the distal circumferential edge to the transition section about the circumference of the brim (Fig. 2).
Claim(s) 12-13 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kurth in view of the ‘635 reference.
Regarding claim 12, Kurth discloses the limitations of the claimed invention, as described above. It further recites the cuff section being configured to move between a tensioned position (downwardly pulled position) and a relaxed position (lax position); and in the relaxed position the cuff section is arranged to extend above or proximally from the socket opening and generally concentric with the outer surface of the socket (Fig. 2; paras. 0028-0029). However, it does not explicitly recite that in the tensioned position the cuff section is arranged to fold downwardly away from the socket opening and generally over an outer surface of the socket. The ‘635 reference teaches a tensioned position where the cuff section is arranged to fold downwardly away from the socket opening and generally over an outer surface of the socket (Figs. 2B, 6; col. 4, lines 13-39), for the purpose of ensuring that the device will comfortably fit over the patient’s residual limb. It would have been an obvious matter of design choice to one having ordinary skill in the art to modify the device of Kurth to comprise a folded, tensioned position, as taught by the’635 reference, in order to ensure that the device will comfortably fit over the patient’s residual limb. Such a modification would be made with a reasonable expectation of success.
Kurth teaches the following regarding claim 13: the brim of claim 12, wherein the interface section defines a lower portion of the brim and is arranged to extend along a surface of the socket in both the tensioned and relaxed positions (Fig. 2).
Regarding claim 16, Kurth discloses the limitations of the claimed invention, as described above. It further recites the supplementary layer having an inner surface interlocking or bonded to the outer surface of the interface section (Fig. 2; paras. 0028-0029). However, it does not explicitly recite that the supplementary layer has an outer surface defining a mesh or porous structure extending at least partially through a thickness of the supplementary layer for engagement with resin of the socket. The ‘635 reference teaches that it is well known in the art that a supplementary layer has an outer surface defining a mesh or porous structure extending at least partially through a thickness of the supplementary layer capable of engagement with resin of the socket (col. 7, lines 45-col. 8, lines 13), for the purpose of helping to secure the liner to the socket. It would have been obvious to one having ordinary skill in the art to modify the supplementary layer of Kurth to comprise a mesh or pores, as taught by the’635 reference, in order to better secure the liner to the socket. Such a modification would be made with a reasonable expectation of success.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ann Hu whose telephone number is (571) 272-6652. The examiner can normally be reached on Monday-Friday (9:00 am-5:30 pm EST).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Jerrah Edwards, at (408) 918-7557. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/ANN HU/Primary Examiner, Art Unit 3774
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