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 .
Priority
Claim 1 contains subject matter not in the priority documents, therefore the earliest priority date for claims 1-5 is 5/12/2022.
Response to Arguments
Applicant's arguments filed 1/5/2026 have been fully considered but they are not persuasive.
With respect to the rejections under 112(b) to claim 4, Applicant amended the claim to specify that the silicone is the subject of the pull resistance but did not further clarify if this is a positively recited method step where the method includes a step of pulling the silicone or if this is merely a claimed characteristic of the silicone. Additionally, “pull resistance prior to breaking” is still unclear. This is not a term of the art and it is not described or defined in enough detail such that a person of skill in the art would be able to determine what the claim means. Claim 4 remains rejected under 112(b).
Applicant argues regarding claim 1 that Laghi cannot be combined with Janusson because Laghi is not analogous art. Applicant argues that Laghi does not disclose a silicone liner and that silicone and the thermoplastic elastomers used in the liner in Laghi are not analogous materials. Examiner does note the previous action erroneously indicated Laghi described silicone liners and notes that Laghi does not use silicone but still describes prosthetic liners. Given that Laghi does describe a prosthetic liner, this is still an analogous field to Janusson’s prosthetic liners.
Applicant additionally argues that Laghi cannot be combined with Janusson would result in an inoperable product because the temperature used in Laghi would be too high to properly mold silicone. Examiner disagrees and notes that the rejection does not rely on the molding temperatures described in Laghi. Laghi is cited only for describing the depth of the microcraters.
Applicant further argues that Janusson requires molding via suction pump and “combining the suction pump requirement of Janusson with the mandrel modification methods described in Claim 1 would result in an inoperative product.” Examiner disagrees. Rejections under 103 rely on a primary reference being combined with or modified by additional references. Janusson is not being combined with the claim. Additionally, Janusson successfully uses a mandrel, male die 252, in the disclosure. Applicant also argues that Janusson teaches away from injection molding. It is not clear how that is relevant to the claim as the claim does not describe injection molding. Dependent claims 2-5 also remain rejected.
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.
Claim 4 is 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 4 recites that the method “further comprises less than 2.4 N of force…” but does not specify if there is a method step of applying a force or if the claim is directed to a characteristic of the material. This will be interpreted to mean that this is a characteristic of the silicone liner rather than an actual method step of pulling the silicone.
Additionally regarding claim 4, the term “pull resistance prior to breaking” does not appear to be a term of the art and does not appear to be defined in the specification. It is not clear what this term means. Examiner will interpret this to mean that the silicone liner can be pulled in any manner at a force less than 2.4 N without breaking.
Claim Rejections - 35 USC § 103
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over Janusson (US 6,485,776) modified by Dignam (US 2012/0179272) and Laghi (US 2006/0111485.)
Regarding claim 1, Janusson meets the claimed, A method of making a silicone liner comprising: molding silicone over the mandrel; (Janusson col. 15 lines 26-49 describe dipping a male die 252 into a silicone elastomer 232) forming fabric sidewalls over the silicone creating a composite (Janusson col. 14 line 65- col. 15 line 12 describe a fabric 101 formed around the silicone elastomer 232) wherein the composite further comprises an open upper end, a closed bottom end, and fabric sidewalls having a thickness (Janusson Figure 1 shows the composite suction liner 10 having an open upper end and a closed distal end area 16) wherein said sidewalls further comprise an inner layer of silicone having a silicone thickness (Janusson Figure 1 shows the silicone layer does have a thickness.)
Janusson does not disclose any particular step of modifying the mandrel surface and does not meet the claimed, modifying a mandrel surface using the method selected from the group consisting of rolling, chemical etching, laser engraving, computer numerical control engraving, electro- erosion, electrodeposition, laser micro melting, shot blasting, shot peening, and pinwheeling.
Analogous in the field of prosthetic liners, Dignam meets the claimed, modifying a mandrel surface using the method selected from the group consisting of rolling, chemical etching, laser engraving, computer numerical control engraving, electro- erosion, electrodeposition, laser micro melting, shot blasting, shot peening, and pinwheeling (Dignam [0056] describes using computer numerical control to shape a male mold part, see Figures 4-5 showing the engraving process.)
It would have been obvious to a person of ordinary skill in the art before the filing date combine the molding process of Janusson with the CNC milling process of Dignam in order to form a custom replica of the patient’s limb and increase comfort, see Dignam [0014].
Janusson does not describe microcraters in the silicone and does not meet the claimed, wherein said silicone has microcraters having a depth between 0.0100 and 0.0195 millimeters.
Analogous in the field of liners, Laghi meets the claimed, wherein said silicone has microcraters having a depth between 0.0100 and 0.0195 millimeters (Laghi [0044] describes microcraters in a silicone liner with a depth of 0.0183 mm – 0.1434 mm.)
The range disclosed in Laghi overlaps the claimed range, in the case where the claimed ranges overlap or lie inside ranges disclosed by the prior art a prima facie case of obviousness exists, see MPEP §2144.05 (II). It would have been obvious to a person of ordinary skill in the art before the filing date to combine the method of making a liner as disclosed in Janusson with the method of forming the microcraters in the claimed range in order to provide a desired tactile feel, and/or to optimize surface characteristics, mechanical properties or other characteristics of the liner, see Laghi [0044].
Regarding claim 2, Janusson meets the claimed, The method of making a silicone liner of Claim 1 wherein the thickness of the sidewalls is between 1.5 and 3 millimeters (Janusson Table 1 and Figure 9 show the thickness of the sidewalls is 3 mm in at least the Thp location.)
Regarding claim 3, Janusson meets the claimed, The method of making a silicone liner of Claim 1 wherein the silicone thickness at the bottom end is between 3 and 12 millimeters (Janusson Table 1 and Figure 6 show the thickness at the bottom end is Tha which is 6 mm.)
Regarding claim 4, The method of making a silicone liner of Claim 1 further comprises less than 2.4 N of force in pull resistance of the silicone prior to breaking (Janusson col. 6 lines 32-22 and lines 66- col. 7 line 4 describe the tensile strength of the fabric and the silicone layer. This meets the claim as can be best interpreted.)
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over modified Janusson as applied to claim 1 above, and further in view of Leung (US 2021/0000621.)
Regarding claim 5, Laghi describes microcraters but does not describe the, The method of making a silicone liner of Claim 1 wherein the microcraters are further formed by compressing silicone against a textured surface after molding but before cooling.
Analogous in the field of prosthetic limb sleeves, Leung meets the claimed, The method of making a silicone liner of Claim 1 wherein the microcraters are further formed by compressing silicone against a textured surface after molding but before cooling.
Leung meets the claimed, The method of making a silicone liner of Claim 1 wherein the microcraters are further formed by compressing silicone against a textured surface after molding but before cooling (Leung [0011] describes perforations can be made in a sleeve via placing the silicone in a positive mold and later cooling.)
It would have been obvious to a person of ordinary skill in the art before the filing date to combine the method of modified Janusson with the method of forming the perforations against a positive mold as described in Leung in order to form channels and perforations that allow moisture to escape the sleeve, see Leung [0009].
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 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.
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/V.B./Examiner, Art Unit 1744
/XIAO S ZHAO/Supervisory Patent Examiner, Art Unit 1744