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.
Claims 12-16 and 18 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. In claim 12, line 2, “of” should be omitted.
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.
Claims 1-7, 12-16, and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Becker, DE 1849778 U, which describes retaining a prosthesis socket 2 “adapted to the shape of the stump in order to achieve a secure and comfortable fit” and supplementing it with insert 1 (drawing; translated specification page at lines 5 and 10-11), which is “precisely adapted to the physical conditions” (ibid.: lines 12-13) and thus has a sealing lip profile 3 determined so as to match the circumferential height contour of a proximal edge of prosthesis socket 2 and the known anatomical stump characteristics (drawing) and arranged on the outer face of the insert or prosthesis liner 1 so as to define a three-dimensional curve and a proximal edge spaced distally from the socket proximal edge because of the “stronger collar” that rests on seal 3 (ibid.: line 16). In order to impart a “comfortable fit” (ibid.: line 5), the cast resin or other suitable material (ibid.: lines 12 and 15) is at least somewhat flexible and elastic by virtue of having a stress-strain function or characteristic. Alternatively, flexible elastic air hose 4 is a base body because it resides along a distal region of insert 1 (drawing).
Regarding amended claim 1, even though air hose 4 serves as a sealing member when inflated and pressurized (ibid.: lines 20-21), only a single sealing lip 3 is arranged “on an outer face of the prosthesis liner along the determined sealing lip profile” (Applicant’s claim 1 at lines 5-9; emphasis added). Regarding amended claims 1 and 12, prior to inflation of air hose 4 or subsequent to its deflation, sealing lip 3 defines, in conjunction with prosthesis liner 1 and prosthesis socket 2, a sealed volume comprising an entire volume between sealing lip 3, prosthesis liner 1, and prosthesis socket 2 distal to sealing lip 3; moreover, nothing in the claim language precludes the sealed volume from being partitioned into a proximal vacuum region, a pressurized air hose 4 region, and a distal region between air hose 4 and a distal end wall of prosthesis socket 2. In fact, Applicant’s claim 12 may include more than one sealing lip and is broad or vague as to whether the sealed, entire volume encompasses all sealing lips or only a distal surface of a distal-most sealing lip.
Regarding claims 2 and 5, the height contour of the proximal edge of socket 2 is detected during manufacture of socket 2 and also detected before the complementarily “precisely adapted” (Becker’s specification: lines 12-13) sealing lip profile is determined. Regarding claim 3, the second option is clearly met by the fixing of Becker’s seal 3 at “the stronger collar” (ibid.: line 16). Regarding claim 7, said collar establishes a sealing lip region that contains and is thus wider than seal or sealing lip 3 and likewise corresponds to the socket 2 proximal edge height contour (drawing). Regarding claim 15, sealing lip 3 is formed or fastened on said collar so as to have varying widths outwardly (drawing) and also along a circumferential dimension by virtue of dissimilar pressures about the socket proximal edge during use. The further limitations of other claims are readily apparent from the drawing in light of the above discussion (MPEP §§ 707 and 2125).
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.
Claims 8-11, 19, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Becker, DE 1849778 U. Regarding claim 8, a sealing lip region twice as wide as sealing lip 3 at its transition to the collar of prosthesis liner 1 would have been obvious to the ordinary practitioner using routine experimentation and/or analysis at the effective filing date of the present invention in order to provide a sufficiently strong collar (specification page: line 16) and adequate retention of sealing lip 3, which itself has a variable width, as explained above relative to Applicant’s claim 15. Regarding claims 9, 19, and 21, optically detecting the circumferential height contour of prosthesis socket 2 for creating a digital 3D model would have been an obvious upgrade in order to more accurately produce a liner 1 geometry matching that of patient-specific socket 2 and “precisely adapted to the physical conditions” (ibid.: lines 12-13, emphasis added; subgroups A61F 2/5046-2002/505 of cooperative patent classification system). Regarding claim 10, determining a sealing lip height would have been obvious from the drawing, which depicts a spacing between an inner circumference of socket 2 and an outer circumference of an amputee’s stump within liner 1, in order to impart a secure and comfortable fit (ibid.: line 5) and to help maintain a vacuum (ibid.: lines 20-21). Regarding claim 11, a rapid liquid printing process would also have been an obvious upgrade in order to more precisely customize liner 1 geometry and features, with Becker indicating that insert or liner 1 may be of a pourable material (Becker’s claim 1).
Response to Arguments
Applicant states that “the [Becker] insert 1 is made of cast resin and does not correspond to a prosthesis liner” (Applicant’s reply of December 10, 2025: page 9, last full paragraph), but “liner” or “lining” is simply defined as “[an] interior coating or covering” (Webster’s II New Riverside University Dictionary, 1984), and insert 1 certainly covers an interior of prosthesis socket 2. Applicant asserts that “[cast] resin is not flexible or elastic”, but “flexible” means “capable of being flexed : PLIANT” (Merriam-Webster’s Collegiate Dictionary, 10th ed.: 1996) with no limitations imposed on magnitudes of flexing forces or stresses. Likewise, “elastic” refers to a solid that is “capable of recovering size and shape after deformation” (ibid.), again without regard to the extent of deformation or the amount of impact or force. Therefore, “flexible and elastic material” (Applicant’s claim 1 at line 12) is not necessarily flaccid or collapsible, as suggested by Applicant in the paragraph bridging pages 9 and 10.
The “suitable material, e.g., cast resin” (Becker translated specification page at line 15) innately possesses an elastic modulus and must be at least somewhat comfortable (ibid.: line 5), and the alternative base body 4 (as set forth in the grounds of rejection) is flexible and elastic in order to receive pressurized air while also functioning as a seal. And even if a more elastic liner were to “collapse” against an inner wall of socket 2 under a vacuum (Applicant’s reply of December 10, 2025: page 10, lines 8-13), such a liner, if snuggly engaging a residual limb of sufficient diameter, would nevertheless help retain the prosthesis on the amputee because of atmospheric pressure acting against the partial vacuum between socket 2 and liner 1, as understood by one of ordinary skill in the art and evidenced by a cursory review of prior art in subclasses 623/34 and 36 of the U.S. patent classification system and subgroups A61F 2/7812+ and 2002/802-807 of the cooperative patent classification system, much of which art involves elastomeric liners. However, the instant claims do not even necessitate elastomeric liners, as previously noted.
Applicant indicates that “Becker does not disclose a vacuum that extends from the seal 3 to envelop the entire insert 1” (Applicant’s reply of December 10, 2025: page 10, last full paragraph), but such a limitation is not commensurate with the scope of the amended claims. A sealed volume could involve various pressures due to gravitational effects and reactive forces and stresses and could even be partitioned, as explained in the grounds of rejection presented above.
Applicant alleges that “a person skilled in the art would not be motivated to optically scan the prosthetic socket 2 of Becker or create a 3D model of a prosthetic liner that fits the prosthetic socket 2 of Becker because the prosthetic socket 2 of Becker does not change” (ibid.: page 11, lines 3-5). Even though the size and shape of a particular prosthetic socket 2 does not change and is deliberately retained (Becker specification at lines 10-11), the Becker system is designed to accommodate both “upper arm and thigh prostheses” (ibid.: line 3; emphasis added) and a diversity of amputees having residual limbs of varying shapes and sizes. The anatomically determined three-dimensional socket curvatures are not readily characterized by measurements from a ruler, tape measure, and/or caliper, so there would have been plenty of motivation to more accurately define one out of the many diverse geometries resulting from the often customized sockets obtained directly from uniquely sized and shaped residual limbs via molding, casting, and even computerized measurements of the limb itself, along with corrections or adjustments based on limb sensitivities and the like, in order to create an insert or liner 1 that is “precisely adapted to the physical conditions” (ibid.: lines 12-13), particularly along the proximal edge of a customized socket 2, where sealing and comfort is required.
Applicant notes that “claim 19 specifically recites optically detecting a very specific part of the prosthetic socket” (Applicant’s reply of December 10, 2025: page 12, lines 1-2), but Becker’s insert 1 is designed to be similarly shaped and sized so as to match and follow such a height and circumferential contour, as explained above and as plainly evident from Becker’s drawing, and optically scanning an entire three-dimensional geometry (including the proximal edge) of a prosthetic socket was known in the art prior to the effective filing date of Applicant’s invention, as seen from Figure 5 and paragraphs 0038, 0048-0050, and 0063 of Tokushima, US 2020/0356073 A1.
Other issues are adequate addressed in the grounds of rejection and/or in the previous Office action of September 10, 2025.
Conclusion
The altered scope of the amended claims necessitated the modified grounds of rejection. Therefore: THIS ACTION IS MADE FINAL. 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 David H. Willse, whose telephone number is 571-272-4762. The examiner can normally be reached on Monday through Thursday. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor Melanie Tyson can be reached at telephone number 571-272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID H WILLSE/ Primary Examiner, Art Unit 3774