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 .
Response to Arguments
Applicant's arguments filed 09/09/26 have been fully considered but they are not persuasive.
On pages 5-6 Applicant argues amendments overcome the outstanding issues.
The Examiner respectfully withdraws objections to the claims and specification as a result. The Examiner respectfully refers to the ejection below regarding amended claims.
Claim Objections
Claims 2 and 12 are objected to because of the following informalities:
Claim 2 is objected to for claiming “the pressure applied by the liner is lower than at the joint both below and above the joint”, but this does not make sense to the Examiner. It appears there may be an issue with word order. Appropriate correction is required.
Claim 12 is objected for the same reasons as claim 2.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-7 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by, Egilsson et al. (US 20150142133 A1) hereinafter known as Egilsson and as is evidenced by Herr (US 20160058519 A1), or in the alternative, as obvious over Egilsson in view of Herr.
Regarding claim 1 Egilsson discloses a liner ([0003]) configured to serve as an interface between an external surface of a biological body segment of a subject and a prosthetic socket, the biological body segment being amputated below a joint (See, for example [0003], and [0009]),
wherein the liner is configured to apply a spatially-varying pressure to the biological body segment based on one or more of a geometry, thickness, or material properties of the liner, the spatially-varying pressure varying over length of the liner (this depends entirely upon a method of use of the liner. Since the liner is capable of experiencing a variable pressure from its outside, which it can transfer to the body segment, the liner meets the limitations of the claim. See also at least figures 1-31e, with particular reference to the areas of increased thickness 305 in figures 24a-c, which show how the geometry and thickness of the liner vary over the length, indicating an inherent variation in pressure it is able to apply to a biological segment).
While Egilsson is silent with regards to the liner being capable of applying a maximum pressure at the joint and a lesser pressure below the joint, the Examiner refers to Herr, who teaches that prosthetic liners generally apply a maximum pressure at the joint (Figure 5b, [0077] shows how when the joint is bent, the maximum pressure and strain occurs at the bended joint), and apply a lesser pressure below the joint (Figure 5b shows the areas below the joint experiencing the lesser pressure and strain). While it is believed that Herr provides evidence that any non-specifically adjusted liner would inherently have this maximum pressure at the area of the liner that corresponds to the bent joint when being donned, in the alternative, the person of ordinary skill would find it obvious in light of Herr, who is in the same field of endeavor of prosthetic liners, to have the maximum pressure at the joint and the lesser pressure below the joint as is described by Herr since this is how liners commonly behave as the joint applies pressure during a bend.
Regarding claim 2 Egilsson discloses, or the Egilsson Herr Combination teaches the liner of claim 1 substantially as is claimed,
wherein, as is best understood, Herr further provides evidence/teaches the pressure applied by the liner is lower than at the joint both below and above the joint (Figure 5b shows the maximum pressure and strain applied to be at the knee and the lower pressure levels surrounding the bent knee).
Regarding claim 3 Egilsson discloses, or the Egilsson Herr Combination teaches the liner of claim 1 substantially as is claimed,
wherein Egilsson further discloses the joint is a knee (this does not appear to structurally alter the claimed liner, which is understood to be capable of being used with an amputee amputated below a knee if desired. See also [0009].).
Regarding claim 4 Egilsson discloses, or the Egilsson Herr Combination teaches the liner of claim 1 substantially as is claimed,
wherein Egilsson further discloses the maximum pressure applied at the joint is greater than 97.5 kPa (this depends entirely upon the maximum pressure applied to the liner, or the degree of the knee bend, or the dimensions of the underlying residual limb, etc. as opposed to structurally altering the claimed liner itself.).
Regarding claim 5 Egilsson discloses, or the Egilsson Herr Combination teaches the liner of claim 1 substantially as is claimed,
wherein Egilsson further discloses the lesser pressure varies between 52.5-97.5 kPa (this depends entirely upon the maximum pressure applied to the liner, or the degree of the knee bend, or the dimensions of the underlying residual limb, etc. as opposed to structurally altering the claimed liner itself.).
Regarding claim 6 Egilsson discloses, or the Egilsson Herr Combination teaches the liner of claim 1 substantially as is claimed,
wherein Egilsson further discloses the liner comprises a first thickness ([0115] distal end thickness) below a cutline (any location which is able to be cut between the proximalmost and distalmost end is understood to be the cutline) and a second thickness ([0115] proximal end thickness) above a cutline (any location which is able to be cut between the proximalmost and distalmost end is understood to be the cutline),
wherein the first thickness is greater than the second thickness ([0115]).
Regarding claim 7 Egilsson discloses, or the Egilsson Herr Combination teaches the liner of claim 6 substantially as is claimed,
wherein Egilsson further discloses the second thickness is between 2-7 mm ([0115]).
Claim(s) 1-5 and 20-22 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Herr et al. (US 20160058519 A1) hereinafter known as Herr.
Regarding claims 1 and 20 Herr discloses a method for interfacing a liner with an external surface of a biological body segment ([0002]-[0003], [0007] the liner interfaces with a skin) amputated below a joint ([0069] the amputee can be a transtibial amputation, which occurs below the knee joint), and liner,
comprising: applying a spatially-varying pressure by the liner to the body segment based on a liner geometry, thickness, or material properties (Figure 5b, [0077] a higher pressure/strain is inherently (or at the least, obviously) applied when the knee of the user is being bent. The liner exhibiting this increase in strain/pressure at the patella during a bend does so based on all its material properties.), the spatially-varying pressure varying over a length of the liner with a maximum pressure applied at the joint and a lesser pressure applied below the joint (Figure 5b, [0077], the pressure is seen to have a maximum pressure at the patella joint, and lesser pressures applied at other locations both above and below the joint).
Regarding claim 2 Herr discloses the liner of claim 1 substantially as is claimed,
wherein, as is best understood, Herr further discloses the pressure applied by the liner is lower than at the joint both below and above the joint (Figure 5b shows the maximum pressure and strain applied to be at the knee and the lower pressure levels surrounding the bent knee).
Regarding claim 3 Herr discloses the liner of claim 1 substantially as is claimed,
wherein Herr further discloses the joint is a knee (this does not appear to structurally alter the claimed liner, which is understood to be capable of being used with an amputee amputated below a knee if desired. See also [0077]).
Regarding claim 4 Herr discloses the liner of claim 1 substantially as is claimed,
wherein Herr further discloses the maximum pressure applied at the joint is greater than 97.5 kPa (this depends entirely upon the maximum pressure applied to the liner, or the degree of the knee bend, or the dimensions of the underlying residual limb, etc. as opposed to structurally altering the claimed liner itself.).
Regarding claim 5 Herr discloses the liner of claim 1 substantially as is claimed,
wherein Herr further discloses the lesser pressure varies between 52.5-97.5 kPa (this depends entirely upon the maximum pressure applied to the liner, or the degree of the knee bend, or the dimensions of the underlying residual limb, etc. as opposed to structurally altering the claimed liner itself.).
Regarding claim 21 Herr discloses the method of claim 20 substantially as is claimed,
wherein, as is best understood, Herr further discloses the pressure applied by the liner is lower than at the joint both below and above the joint (Figure 5b shows the maximum pressure and strain applied to be at the knee and the lower pressure levels surrounding the bent knee).
Regarding claim 22 Herr discloses the method of claim 20 substantially as is claimed,
wherein Herr further discloses the joint is a knee ([0077]).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Egilsson, or over Egilsson in view of Herr as is applied above, further in view of Cain et al. (US 20230115195 A1) hereinafter known as Cain.
Regarding claim 8 Egilsson discloses, or the Egilsson Herr Combination teaches the liner of claim 1 substantially as is claimed,
but is silent with regards to whether or not the liner is fabricated using a direct write 3d printing.
However, regarding claim 8 Egilsson teaches their liner is made of silicone ([0070]), and Cain teaches that silicone liners (Abstract, [0007]), can be 3d printed via a direct-write soft material 3d printing technique ([0011], [0067]). Egilsson and Cain are involved in the same field of endeavor, namely prosthetic liners. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the liner of Egilsson or the Egilsson Caspers Combination so that its liner is printed via a direct-write process as is taught by Cain since the courts have held that the use of a known technique or method to improve a known device results in a prima facie case of obviousness. See MPEP 2143 (I)(C).
Regarding claim 9 the Egilsson Cain Combination, or the Egilsson Caspers Cain Combination teaches the liner of claim 8 substantially as is claimed,
wherein Egilsson further discloses the liner is fabricated using silicone ([0070]),
wherein Cain further teaches prosthetic liners can be manufactured from platinum cure silicone or polyurethane ([0067]-[0068] MED-4901, -3640, 6345 are platinum-catalyzed ). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the liner of the Egilsson Cain Combination, or the Egilsson Caspers Cain Combination so it is manufactured with platinum cure silicone or polyurethane as is taught by Cain it has been held by the courts that selection of a prior art material on the basis of its suitability for its intended purpose is within the level of ordinary skill. See MPEP 2144.07. In this case, the use of any material suitable to use within a liner is considered obvious to a person of ordinary skill to select.
Claims 6-7 and 25-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Herr in view of Egillson as is applied above.
Regarding claim 6 Herr discloses the liner of claim 1 substantially as is claimed,
but is silent with regards to the liner having a first and second thickness.
However, regarding claim 6 Egilsson teaches a prosthetic liner that comprises a first thickness ([0115] distal end thickness) below a cutline (any location which is able to be cut between the proximalmost and distalmost end is understood to be the cutline) and a second thickness ([0115] proximal end thickness) above a cutline (any location which is able to be cut between the proximalmost and distalmost end is understood to be the cutline),
wherein the first thickness is greater than the second thickness ([0115]). Herr and Egilsson are involved in the same field of endeavor, namely prosthetic liners. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the liner of Herr so that the liner has a variable thickness as is taught by Egilsson in order to ensure the bony protuberances at the distal end are adequately cushioned during use, as these receive the full weight of the user.
Regarding claim 7 the Herr Egilsson Combination teaches the liner of claim 6 substantially as is claimed,
wherein Egilsson further teaches the second thickness is between 2-7 mm ([0115]).
Regarding claim 25 Herr discloses the method of claim 20 substantially as is claimed,
wherein Herr further discloses but is silent with regards to the liner having a first and second thickness.
However, regarding claim 25 Egilsson teaches a prosthetic liner that comprises a first thickness ([0115] distal end thickness) below a cutline (any location which is able to be cut between the proximalmost and distalmost end is understood to be the cutline) and a second thickness ([0115] proximal end thickness) above a cutline (any location which is able to be cut between the proximalmost and distalmost end is understood to be the cutline),
wherein the first thickness is greater than the second thickness ([0115]). Herr and Egilsson are involved in the same field of endeavor, namely prosthetic liners. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the liner of Herr so that the liner has a variable thickness as is taught by Egilsson in order to ensure the bony protuberances at the distal end are adequately cushioned during use, as these receive the full weight of the user.
Regarding claim 26 the Herr Egilsson Combination teaches the method of claim 25 substantially as is claimed,
wherein Egilsson further teaches the second thickness is between 2-7 mm ([0115]).
Claims 23-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Herr as is applied above, in view of Zhang et al. “Clinical investigation of the pressure and shear stress on the trans tibial stump with a prosthesis.” Medical Engineering & Physics 20 (1998) 188-198, hereinafter known as Zhang.
Regarding claim 23 Herr discloses the method of claim 20 substantially as is claimed,
but is silent with regards to the maximum pressure applied at the joint is greater than 97.5 kPA.
However, regarding claim 23 Zhang teaches that within an interface between a residual limb and liner (page 188, column 2 paragraph 2: transducers between the skin and socket liner) include both a location at a joint (Figure 1, for example, PD), and a location below the joint (Figure 1, for example, KP), where the maximum pressure applied at the joint is greater than 97.5 kPa (Figure 5, PD graph which shows a maximum pressure of greater than 300 kPa; page 194 column 1 paragraph 2 Figure 5 shows the curves of pressure). Herr and Zhang are involved in the same field of endeavor, namely socket-limb interface systems. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the method of Herr so that the maximum pressure at the joint is greater than 97.5 kPa as is taught by Zhang since this is a known value for maximum pressure at and around the knee during use of a prosthesis, and thus expected to be seen.
Regarding claim 24 Herr discloses the method of claim 20 substantially as is claimed,
but is silent with regards to the lesser pressure varies between 52.5-97.5 kPA.
However, regarding claim 24 Zhang teaches that within an interface between a residual limb and liner (page 188, column 2 paragraph 2: transducers between the skin and socket liner) include both a location at a joint (Figure 1, for example, PD), and a location below the joint (Figure 1, for example, KP), where a lesser pressure below the knee is seen to have a value between 52.5-97.5 kPa (Figure 5, KP graph which shows a variety of pressures occurring within the claimed range; page 194 column 1 paragraph 2 Figure 5 shows the curves of pressure). Herr and Zhang are involved in the same field of endeavor, namely socket-limb interface systems. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the method of Herr so that the lesser pressure falls within the claimed range as is taught by Zhang since this is a known value for pressures at locations other than at the knee at and around the knee during use of a prosthesis, and thus expected to be seen.
Claims 27-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Herr in view of Cain as are applied above.
Regarding claim 27 Herr discloses the method of claim 20 substantially as is claimed,
but is silent with regards to whether or not the liner is fabricated using a direct write 3d printing.
However, regarding claim 27 Herr teaches their liner can be made of silicone ([0003]), and Cain teaches that silicone liners (Abstract, [0007]), can be 3d printed via a direct-write soft material 3d printing technique ([0011], [0067]). Herr and Cain are involved in the same field of endeavor, namely prosthetic liners. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the liner of Herr so that its liner is printed via a direct-write process as is taught by Cain since the courts have held that the use of a known technique or method to improve a known device results in a prima facie case of obviousness. See MPEP 2143 (I)(C).
Regarding claim 28 Herr discloses the method of claim 27 substantially as is claimed,
wherein Herr further discloses the liner is fabricated using silicone ([0003]),
wherein Cain further teaches prosthetic liners can be manufactured from platinum cure silicone or polyurethane ([0067]-[0068] MED-4901, -3640, 6345 are platinum-catalyzed ). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the liner of Herr so it is manufactured with platinum cure silicone or polyurethane as is taught by Cain it has been held by the courts that selection of a prior art material on the basis of its suitability for its intended purpose is within the level of ordinary skill. See MPEP 2144.07. In this case, the use of any material suitable to use within a liner is considered obvious to a person of ordinary skill to select.
Conclusion
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 extension fee 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 Jacqueline Woznicki whose telephone number is (571)270-5603. The examiner can normally be reached M-Th 10am-6pm EST.
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 on 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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/Jacqueline Woznicki/Primary Examiner, Art Unit 3774
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