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 .
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.
Election/Restrictions
Applicant’s amendment filed April 29, 2026 uses the status indicator of “Previously Presented” for dependent claim 7. However, as indicated in the non-final office action dated November 28, 2025, claim 7 is withdrawn from consideration as being drawn to non-elected species F, not elected species E. For example, paragraph [104] of the originally filed specification describes “the sealing portion on an inner surface of the body extends between the proximal edge of the body and the connection point”. Despite use of incorrect status identifier for claim 7, Applicant has not traversed indication of claim 7 as being withdrawn from consideration. Applicant should update the status indicator of claim 7 to “withdrawn” in any future filings.
Response to Arguments
Claims have been amended to require “…at least one seal element attached to and separate from the body…”; “the at least one seal element is formed from a softer material than a material forming the body”; and “…the body defines one or more raised portions molded on the outer surface of the body and…”. The first and third of these claim amendments were addressed during the interview held on April 2, 2026 (see 4/29/2026 interview summary for details). As discussed during the interview, the claim was further amended to include the second abovementioned claim amendment, which distinguishes the claims from the rejection of record. Thus, Applicant’s arguments, see supplemental amendment and remarks, filed April 29, 2026, with respect to the rejection of claims 1-2, 6, 8 and 11-13 under 35 U.S.C. 103 as being unpatentable over Egilsson et al. U.S. publication no. 2015/0142133 A1 (“Egilsson”) in view of Fikes U.S. patent no. 9,155,636 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of additional prior art and/or considerations.
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 1-2, 6, 8 and 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Egilsson et al. U.S. publication no. 2015/0142133 A1 (“Egilsson-2015-publication”) in view of Fikes U.S. patent no. 9,155,636 and further in view of Egilsson et al. U.S. publication no. 2007/0123998 A1 (“Egilsson-2007-publication).
Regarding claim 1, in at least the embodiment of figures 27-29B, Egilsson-2015-publication discloses an adjustable seal system for providing an interface between a residual limb and a prosthetic socket, the adjustable seal system (figures 27-29B), comprising: a seal component (600) arranged for removably securing to an outer surface of a prosthetic liner (paragraph [0132]), the seal component (600) including: a body (601- figures 27 and 28B) having an open upper (627) and lower (608) ends (figures 27-29) and an inner surface (626) defining an opening therethrough (figure 29A), and an outer surface opposite the inner surface (626) (e.g., figures 29A-29B); a socket sealing portion (604) on the outer surface of the body (paragraph [0137]; figures 27 and 29A) and arranged to engage and form an airtight seal with an interior surface of the prosthetic socket (e.g., see at least paragraph [0139], figures 27-29B); and a liner sealing portion (608) on the inner surface of the body (601) arranged to frictionally engage and seal with the outer surface of the prosthetic liner (e.g., see at least paragraph [0140] and figures 27 and 29A-29B); wherein the socket sealing portion (604) comprises at least one seal element (604) spaced by a clearance (610) from the outer surface of the body (601) of the seal component (604) (e.g., see at least paragraph [0138] and figures 27 and 29A-29B).
Egilsson-2015-publication is silent regarding the body defines one or more raised portions radially positioned between the at least one seal element and a body profile of the outer surface of the body, the one or more raised portions being configured to create channels for airflow between the at least one seal element and the body profile.
In the same field of endeavor, namely prosthetic systems for providing an interface between a residual limb and a prosthetic socket, Fikes teaches a body (20) defines one or more raised portions (28) (i.e., tubes attached/formed on an outer surface of the body forms raised portions as are they are attached to the outer surface of body – see at least figures 1-4; and col. 3, lines 65-66; and col. 4, lines 10-13) radially positioned between at least one seal element (52, 54) and a body profile (20) of the outer surface of the body (e.g., see at last figures 1-4; and col. 3, lines 59-66), the one or more raised portions (28) being configured to create channels for airflow between the at least one seal element and the body profile (e.g., see at least figures 1-4 and 6A; and col. 6, lines 15-18; and air channels 28 as described throughout specification).
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the claimed invention to modify the invention of Egilsson-2015-publication to include the one or more raised portions of Fikes, defined in the body of the seal element of Egilsson and radially positioned between the at least one seal element and a body profile of the outer surface of the body of Egilsson-2015-publication, such that the one or more raised portions of Fikes added to the invention of Egilsson-2015-publication being configured to create channels for airflow between the at least one seal element and the body profile of Egilsson-2015-publication in order to aid in ease of donning and doffing of prosthetic socket with predictable results and a reasonable expectation of success.
Fikes further expressly teaches, “"In some implementations the air channels 28 may be attached to the liner 14 with a glue and the flap 32 of the selective two-way valve 30 may also be attached to the liner 14 with a glue. Those of ordinary skill in the art will readily be able to select appropriate materials and manufacture these products from the disclosures provided herein" (col. 10, lines 43-48). Thus, Fikes teaches the air channels may be formed as one or more raised portions on the outer surface of the body (e.g., in implementation on the outer surface of the body by being glued thereto). However, while Examiner agrees that Fikes fails to expressly teach an iteration of materials and manufacture that includes the air channels being specifically "molded" to the outer surface, Fikes does expressly teach and/or fairly suggest that any appropriate manufacture of these products may be used as appropriate. Moreover, it has been held “that the use of a one-piece construction instead of the structure disclosed in [the prior art] would be merely a matter of obvious engineering choice.” In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965). Moreover, it has been held that in the absence of an unexpected outcome or special need for doing so, making two separate parts into an integral device is merely a matter of design choice. MPEP 2144.04 (V)(B). In the instant case, molding the raised air channel onto the outer surface of the device of Egilsson in view of Fikes does not produce any unexpected result or provide a solution for any special or unexpected need. Rather, the limitation combines two features already expressly disclosed as possible manufacture material and manufacture, namely molding of the air channel and inclusion of the air channel on the outer surface of the body. Rather, Fikes appears to suggest combining disclosed manufacture methods and materials in col. 10, lines 43-48 (see above) and molding the air channels to an outer surface may be a matter of design choice obvious to one of ordinary skill in the art at the time of the invention for the benefit of reducing manufacturing costs (e.g., no further step and/or materials needed for gluing step), while providing the air channel at a known location, namely on a body profile of the outer surface of the body, that is already expressly disclosed by the prior art to Fikes. Thus, the claim amendment does not appear to provide a patentable novelty over the known features of the prior art.
Egilsson-2015-publication in view of Fikes is further silent regarding the at least one seal element attached to and separate from the body and formed from a softer material than a material forming the body substantially as claimed.
In the same field of endeavor, namely prosthetic socket systems, Egilsson-2007-publication teaches “…alternatively [seal elements], could be formed separately of a softer or stiffer material or a material more suitable for a seal than the material forming the liner sleeve body portion, and then secured to the liner sleeve” (paragraph [0059]).
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the claimed invention to form the at least one seal element attached to and separate from the body and formed from a softer material than a material forming the body in the invention of Egilsson-2015-publication in view of Fikes, as taught and/or suggested by Egilsson-2007-publication, in order to select the most suitable material for the at least one seal for with predictable results and a reasonable expectation of success.
Regarding claim 2, as described supra, Egilsson-2015-publication in view of Fikes in view of Egilsson-2007-publication teaches the invention substantially as claimed. Egilsson-2015-publication [primary reference] is simply silent regarding a sealing length of the liner sealing portion. Therefore, . Egilsson-2015-publication is silent regarding the sealing length of the liner sealing portion is about 30mm substantially as claimed. One of ordinary skill in the art at the time of the invention would recognize the sealing length of the liner sealing portion as being a result effecting variable, selected in order to optimize the ability of the sealing portion to create a seal of a desired sealing strength between the liner sealing portion and the prosthetic liner. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to form the sealing length of the liner sealing portion as about 30mm in order to select an appropriate or optimize sealing length to achieve the desired sealing strength between the liner sealing portion and the prosthetic liner with predictable results and a reasonable expectation of success. Indeed, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. Also see MPEP 2144.04.
Regarding claim 6, Egilsson-2015-publication discloses the socket sealing portion (604) comprises at least one seal element (604) cantilevered from a connection point connecting the at least one seal element to the outer surface of the body (e.g., see at least figure 29B).
Regarding claim 8, Egilsson-2015-publication discloses the liner sealing portion (608) comprises an interior wall forming at least part of the inner surface of the body (e.g., figures 27 and 29A-29B), and the proximal edge of the body comprises an upper free end of the interior wall (e.g., see at least figures 27-29).
Regarding claim 11, Fikes, as applied in the invention of Egilsson-2015-publication in view of Fikes in view of Egilsson-2007-publication, further teaches the one or more raised portions (28) comprise a linear protrusion extending in a direction between the upper and lower ends of the body of Egilsson-2015-publication (e.g., see at least figure 1-4 of Fikes).
Regarding claim 12, Fikes, as applied in the invention of Egilsson-2015-publication in view of Fikes in view of Egilsson-2007-publication, further teaches the one or more raised portions (28) comprise a plurality of linear portions extending in a direction between the upper and lower ends of the body (e.g., see at least figures 1-4 and col. 8, lines 6-8 of Fikes).
Regarding claim 13, Fikes, as applied in the invention of Egilsson-2015-publication in view of Fikes in view of Egilsson-2007-publication, further teaches the one or more raised portions (28) comprise a plurality of linear portions extending in an oblique direction between the open upper and lower ends of the body (e.g., see at least figures 1-5, 7 and 8 of Fikes).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Bjarnason U.S. Patent no. 7,118,602 discloses linear raised portions on an outer body surface, wherein an ‘air channel’ may be formed between two adjacent raised portions (e.g., see at least figures 7-9; and col. 5, lines 28-35; and col. 11, lines 1-4; etc.).
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 MARCIA LYNN WATKINS whose telephone number is (571)270-1456. The examiner can normally be reached Mon. & Tues. 3-8pm and Thurs. 12-6pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerrah Edwards can be reached 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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/MARCIA L WATKINS/Primary Examiner, Art Unit 3774
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