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 Amendment filed 11/12/2025 has been entered. Claims 1-16 and 18-28 are currently pending in this application.
Response to Arguments
Applicant's arguments filed 11/12/2025 have been fully considered but they are not persuasive. With regard to applicant’s argument that Egilsson does not teach the newly added limitation that the sealing element extends from a central point of the sealing element base, the examiner disagrees. See rejection below for further explanation.
Claim Objections
Claims 1 and 23 are objected to because of the following informalities:
Claim 1 recites “the sealing element” in line 8, which appears to be referring to – the at least one sealing element –, as recited earlier in the claim.
Claim 23 recites the preamble “The suspension liner”, which appears to be referring to – The suspension liner sleeve –, as recited in claim 16. It is noted that the current claim set indicates that claim 23 is currently amended, however, no amendments are shown.
Appropriate correction is required.
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 1-15 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 1 recites the limitation "a thermoplastic elastomer material" in line 7. It is unclear whether the thermoplastic elastomer material is referring to the cushioning material or whether it is an additional element. For the purpose of further examination, the examiner interprets this limitation as referring to the cushioning material as recited earlier in the claim.
Claim Rejections - 35 USC § 102
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 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) 1-11, 14-16, 18-24, and 27-28 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent No. 7,025,793 B2 to Egilsson (Egilsson).
Regarding at least claim 1
Egilsson teaches a suspension liner sleeve providing an interface between a residual limb and a hard prosthetic socket that includes a resilient seal element (abstract).
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Egilsson meets the limitations of a suspension liner sleeve configured to create a vacuum between a residual limb and a prosthetic socket (abstract and col. 6, lines 6-10 disclose a liner sleeve that enables evacuation between the seal and the socket) comprising: an elongate, tubular body portion (8) comprising a cushioning material (col. 6, lines 15-16 discloses an elastomeric cushioning material) having a tubular thickness, a vertical axis, defining an open proximal end and a closed distal end (fig. 4 shows a tubular thickness, vertical axis, open proximal end, and a closed distal end); a fabric exterior layer (reinforcement material; 4) bonded to the tubular body portion (col. 4, lines 30-47 discloses that the reinforcement material may be located externally of the elastomer, such as a textile cover on the elastomer liner sleeve body); and at least one sealing element (9) bonded to the said fabric exterior layer which is non-unitary with a thermoplastic elastomer material (interpreted as the cushioning material – see 112 rejection above) of the tubular body portion (col. 6, lines 17-21 discloses the sealing element as being formed separately from the liner body portion and securely attached/bonded thereto) wherein the sealing element further comprises a sealing element base and a single engaging member which extends radially outward from a central point of the sealing element base (annotated figs. 26 and 27 below, for example, each show a base and single engaging member that extends radially outward from a central point of the base, as claimed – the engaging member extends from a central point of the base, particularly since the term “central” is defined as: containing or constituting a center; situated at, in, or near the center).
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Regarding at least claim 2
Egilsson teaches the suspension liner sleeve of Claim 1 wherein the engaging member is substantially straight (col. 8, lines 48-65 discloses various profiles of the seal element, including one with a substantially straight engaging member).
Regarding at least claim 3
Egilsson teaches the suspension liner sleeve of Claim 1 wherein the engaging member is arcuate (col. 8, lines 48-65 discloses various profiles of the seal element, including one with an arcuate engaging member).
Regarding at least claim 4
Egilsson teaches the suspension liner sleeve of Claim 1 wherein the tubular body portion (8) further comprises a distal lock at the closed distal end (fig. 1 shows a distal lock at the closed distal end of the body portion).
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Regarding at least claim 5
Egilsson teaches the suspension liner sleeve of Claim 1 wherein the suspension liner sleeve incorporates at least three sealing elements (fig. 5 shows at least three sealing elements).
[AltContent: arrow][AltContent: arrow][AltContent: arrow][AltContent: textbox (About one third of a distance)][AltContent: textbox (At a mid-point)][AltContent: textbox (At the closed distal end)]
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Regarding at least claim 6
Egilsson teaches the suspension liner sleeve of Claim 1 wherein the at least one sealing element is bonded at a mid-point along the suspension liner sleeve (fig. 5 shows a sealing element bonded at a mid-point along the liner body).
Regarding at least claim 7
Egilsson teaches the suspension liner sleeve of Claim 1 wherein the at least one sealing element is bonded about one third of a distance from the closed distal end towards the open proximal end (fig. 5 shows a sealing element bonded about one third of a distance from the closed distal end towards the open proximal end of the liner body).
Regarding at least claim 8
Egilsson teaches the suspension liner sleeve of Claim 1 wherein the at least one sealing element is bonded at the closed distal end (fig. 5 shows a sealing element bonded at/closest to the closed distal end).
Regarding at least claim 9
Egilsson teaches the suspension liner sleeve of Claim 5 wherein a first sealing element is bonded at a mid-point along the suspension liner sleeve, a second sealing element is bonded about one third of a distance from the closed distal end and towards the open proximal end, and a third sealing element is bonded at the closed distal end (fig. 5 shows a first sealing element bonded at a mid-point along the liner body, a second sealing element bonded about one third of a distance from the closed distal end and towards the open proximal end, and a third sealing element bonded at/closest to the closed distal end).
Regarding at least claim 10
Egilsson teaches the suspension liner sleeve of Claim 1 wherein the cushioning material comprises silicone (col. 6, lines 15-16 discloses silicone).
Regarding at least claim 11
Egilsson teaches the suspension liner sleeve of Claim 1 wherein the cushioning material comprises an elastomeric compound (col. 6, lines 15-16 discloses an elastomeric material such as silicone).
Regarding at least claim 14
Egilsson teaches the suspension liner sleeve of Claim 10 wherein the at least one sealing element comprises an elastomeric compound (col. 5, lines 9-10 discloses that the seal element could be formed of the same silicone material as the liner sleeve body portion).
Regarding at least claim 15
Egilsson teaches the suspension liner sleeve of Claim 11 wherein the at least one sealing element comprises silicone (col. 5, lines 9-10 discloses that the seal element could be formed of the same silicone material as the liner sleeve body portion).
Regarding at least claim 16
Egilsson meets the limitations of a suspension liner sleeve configured to create a vacuum between a residual limb and a prosthetic socket (abstract and col. 6, lines 6-10 disclose a liner sleeve that enables evacuation between the seal and the socket) comprising: an elongate, tubular body portion (8) comprising a cushioning material (col. 6, lines 15-16 discloses an elastomeric cushioning material) having a tubular thickness, a vertical axis defining an open proximal end and a closed distal end (fig. 4 shows a tubular thickness, vertical axis, open proximal end, and a closed distal end), and a distal lock integrally within the closed distal end (see annotated fig. 1 above that shows a distal lock); a fabric exterior layer (reinforcement material; 4) bonded to the tubular body portion (col. 4, lines 30-47 discloses that the reinforcement material may be located externally of the elastomer, such as a textile cover on the elastomer liner sleeve body); and at least one sealing element (9) bonded to the said fabric exterior layer which is non-unitary with the cushioning material of the tubular body portion (col. 6, lines 17-21 discloses the sealing element as being formed separately from the liner body portion and securely attached/bonded thereto) wherein the sealing element further comprises a sealing element base and a single straight engaging member which extends radially outward from a central point of the sealing element base (annotated fig. 27 above, for example, shows a base and single straight engaging member that extends radially outward from a central point of the base, as claimed – the engaging member extends from a central point of the base, particularly since the term “central” is defined as: containing or constituting a center; situated at, in, or near the center).
Regarding at least claim 18
Egilsson teaches the suspension liner sleeve of Claim 16 wherein the suspension liner sleeve incorporates at least three sealing elements (fig. 5 shows at least three sealing elements incorporated into the liner body).
Regarding at least claim 19
Egilsson teaches the suspension liner sleeve of Claim 16 wherein the at least one sealing element is bonded at a mid-point along the suspension liner sleeve (fig. 5 shows a sealing element bonded at a mid-point along the liner body).
Regarding at least claim 20
Egilsson teaches the suspension liner sleeve of Claim 16 wherein the at least one sealing element is bonded about one third of a distance from the closed distal end towards the open proximal end (fig. 5 shows a sealing element bonded about one third of a distance of the liner body towards the open proximal end as claimed).
Regarding at least claim 21
Egilsson teaches the suspension liner sleeve of Claim 16 wherein the at least one sealing element is bonded at the closed distal end (fig. 5 shows a sealing element bonded at/closest to the distal end).
Regarding at least claim 22
Egilsson teaches the suspension liner sleeve of Claim 20 wherein a first sealing element is bonded at a mid-point along the suspension liner sleeve, a second sealing element is bonded about one-third of a distance from the closed distal end towards the open proximal end, and a third sealing element is bonded at the closed distal end (fig. 5 shows a first, second, and third sealing element bonded at the claimed locations).
Regarding at least claim 23
Egilsson teaches the suspension liner of Claim 16 wherein the cushioning material is silicone (col. 6, lines 15-16 discloses an elastomeric material such as silicone).
Regarding at least claim 24
Egilsson teaches the suspension liner sleeve of Claim 16 wherein the cushioning material is an elastomeric compound (col. 6, lines 15-16 discloses an elastomeric material such as silicone).
Regarding at least claim 27
Egilsson teaches the suspension liner sleeve of Claim 23 wherein the sealing element comprises an elastomeric compound (col. 5, lines 9-10 discloses that the seal element could be formed of the same silicone material as the liner sleeve body portion).
Regarding at least claim 28
Egilsson teaches the suspension liner sleeve of Claim 24 wherein the sealing element comprises silicone (col. 5, lines 9-10 discloses that the seal element could be formed of the same silicone material as the liner sleeve body portion).
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) 12, 13, 25, and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Egilsson.
Regarding at least claims 12 and 25
Egilsson teaches the suspension liner sleeve of Claims 11 and 24 including that the cushioning material is an elastomeric compound. However, Egilsson does not teach wherein the elastomeric compound is urethane.
It would have been obvious to one having ordinary skill int eh art before the effective filing date of the claimed invention to modify the elastomeric compound of the cushioning material of Egilsson is urethane, since it is prima facie obvious to select a known material based on its suitability for an intended purpose (See MPEP 2144.07).
Regarding at least claims 13 and 26
Egilsson teaches the suspension liner sleeve of Claims 11 and 24 including that the cushioning material is an elastomeric compound. However, Egilsson does not teach wherein the elastomeric compound is a thermoplastic elastomeric gel.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the elastomeric compound of the cushioning material of Egilsson is a thermoplastic elastomeric gel, since it is prima facie obvious to select a known material based on its suitability for an intended purpose (See MPEP 2144.07).
Conclusion
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 MELISSA A HOBAN whose telephone number is (571)270-5785. The examiner can normally be reached Monday-Friday 8:00AM-5:00PM.
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, Melanie Tyson can be reached at 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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/M.A.H/Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774