DETAILED ACTION
This Office Action is in response to the Amendment filed January s28, 2026. The specification and claims 1, 9, 13, 22 and 23 have been amended, and claims 6 and 8 have been cancelled. Claims 1-5, 7, 9-13 and 19-26 are pending.
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 Amendment
In response to the amendment the objections to the specification and drawings, claims 1, 9 and 13, the 112 (b)(1) rejections of claims 1-13 and 19-26, and the 101 rejection of clams 1-13 and 19-26 have been withdrawn.
Response to Arguments
Applicant's arguments filed January 28, 206 with respect to the 102(a)(10) rejection of Claims 1, 3, 7, 9-11, 19-21 with respect to Carlson have been fully considered but they are not persuasive. Applicant essentially argues that the none of the cited references anticipate claim 1 as amended. However, Carlson discloses a friction barrier that comprises polytetrafluoroethylene. Note the amended rejection below which incorporates Applicant’s newly added claim language.
With respect the 102 rejection of claims 1 and 9 as being anticipated by Scheinberg, while the examiner does not concede that Scheinberg does not anticipate claims 1 and 9, the examiner has withdrawn this rejection for the sake of compact prosecution.
With respect to the 103 rejections of claims 2, 6, 22, 23, 25 and 26 Applicant argues that none of the none of the cited references alone or in combination demonstrate the obviousness of claim 1 as amended. However, the examiner disagrees. As can be seen from the obviousness rejections of the clams 2, 22, 23, 25 and 26 below, the prior art of Carlson, Francis, UHMW, Ostan and Epler and Boralis render the claims obvious.
In response to Applicant’s argument that currently amended claim 1 and those that depend therefrom are allowable, the Office disagrees. As evidenced by the rejections below claims 1-5, 7, 9-12 and 19-26 remain rejection.
Applicant’s arguments, filed January 28, 2028, with respect to the 102 (a)(1)rejection(s) of claim(s) 1, 4, 5, 9, 11 and 12 as being anticipated by Francis, 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 Therefore, the rejection has been withdrawn.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 Francis, as evidenced by Boralis, in view of UHMW.
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, 3, 7, 9-11, 19-21 and 24 is/are rejected under 35 U.S.C. 102(A)(1) as being anticipated by U.S. Patent No. 8,097,766 (hereinafter Carlson).
Regarding claim 1, Carlson discloses a self-adhering friction reducing liner and method of use that anticipates Applicant’s presently claimed invention. More specifically, Carlson discloses a blister prevention apparatus (PTFE film layer 72, see Fig. 9 and col. 7, lines 44-45) adapted to be positioned between a support surface and a skin surface (see the abstract), wherein said friction barrier comprises a generally flat sheet material (see Fig. 9) generally conformable by placement between said support surface and said skin surface, or a pre-formed material placed between said support surface and said skin surface (col. 3, lines 25-30, the PTFE sheet is conformable to irregular shapes or surfaces and col. 7, lines 33-36), wherein said friction barrier has a first side (73) adapted to face said skin surface (col. 7, lines 46-52) having a static coefficient of friction (fr) of less than 0.2 (it is constructed from polytetrafluoroethylene, which Applicant identifies the specification as having a coefficient of friction less than 0.2), wherein said friction barrier comprising a compound, said compound selected from a group of compounds consisting of polyoxymethylene copolymer, polyoxymethylene homopolymer, polyethylene terephthalate, high-density polyethylene, ultra-high molecular weight polyethylene, polytetrafluoroethylene, fluorinated ethylene propylene, perfluoroalkoxy alkane, and combinations thereof; and wherein anyone of said compounds in said group being selectable as said compound (note the disclosure of polytetrafluoroethylene (PTFE) at col. 7, lines 44-45).
Regarding claim 3, Carlson discloses the apparatus of claim 1, wherein said generally flat sheet material comprises or essentially consists of one material (PTFE layer is comprises one material, namely, PTFE).
Regarding claim 7, Carlson discloses the apparatus of claim 1, wherein said first side adapted to face said skin surface having a static coefficient of friction (fr) of less than 0.15 (note the Fig. 33 of the instant application which discloses PTFE has a coefficient of friction less than 0.15).
Regarding claim 8, Carlson discloses the apparatus of claim 7, wherein said first side adapted to face said skin surface having a static coefficient of friction (fr) of less than 0.15 comprises one or more of: polytetrafluoroethylene, fluorinated ethylene propylene, and perfluoroalkoxy (note the Fig. 33 of the instant application which discloses PTFE has a coefficient of friction less than 0.15).
Regarding claim 9, Carlson discloses the apparatus of claim 1, wherein said generally flat sheet material generally conformable by placement between said support surface and said skin surface or said pre-formed material placed between said support surface and said skin surface, comprises a plurality of layers, wherein a first layer including said first side adapted to face said skin, and wherein a second layer PTFE film 68) including said second side adapted to face said support surface (see outer surface 69), wherein said first layer adapted to face said skin surface having said static coefficient of friction of less than 0.2 (note the Fig. 33 of the instant application which discloses PTFE has a coefficient of friction less than 0.15).
Regarding claim 10, Carlson discloses the apparatus of claim 9, wherein said first layer and said second layer integrated as one piece (see col. 7, lines 32-40, which discloses the first and second layers are bonded to stretch fabric 70, thereby being integrated as one piece).
Regarding claim 11, Carlson discloses the apparatus of claim 9, wherein said first layer and said second layer each comprise a separate discrete layer (see Fig. 9 which shows first and second layers are separated discrete layers).
Regarding claim 19, Carlson discloses the apparatus of claim 1, wherein said friction barrier configured to generally conform to said skin surface of a human foot (as can be seen from Fig. 10, the patches can be used on the human foot and therefore are configure to generally conform to the skin surface of a human foot).
Regarding claim 20, Carlson discloses the apparatus of claim 19, wherein said friction barrier is configured to generally conform to said skin surface of a heel of a human foot (as can be seen from Fig. 10, the patches in Carlson can be used on the heel of a human foot and therefore are configured to generally conform to said skin surface of a heel).
Regarding claim 21, Carlson discloses the apparatus of claim 20, wherein said friction barrier configured to generally conform to said skin surface of said heel of said human foot, includes a plantar heel portion and a back heel portion (as can be seen from Fig. 10, the patches in Carlson can be used on the heel of a human foot and therefore are configured to generally conform to said skin surface of a heel including a plantar heel portion and a back heel portion).
Regarding claim 24, Carlson discloses the apparatus of claim 19, wherein said friction barrier is configured to generally conform to said skin surface of a plantar forefoot of said human foot (as can be seen from Fig. 10, the patches in Carlson can be used on the heel of a human foot and therefore are configured to generally conform to said skin surface of a heel including a plantar forefoot).
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
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carlson in view of U.S. Patent No. 11,285,050 (“Ostan et al.”)
Regarding claim 22, Carlson discloses the apparatus of claim 20, except further comprising an ankle cover portion outwardly extending from a back heel portion to cover a skin surface of an inner ankle of said human foot or a skin surface of an outer ankle, and a combination thereof (as interpreted).
However, Ostan et al. in an analogous friction reducing device (dressing 1) comprising an ankle cover portion (62, 64, see Figs. 4c, 4g and 5), extending from a back heel portion (12 and 13) to cover a skin surface of an inner ankle and outer ankle (col. 13, lines 8-14) in order to prevent pressure ulcers (see col. 2, lines 1-25).
In view of Ostan et al., it would have been obvious to one having ordinary skill in the art before the effective tine of filing the claimed invention to constructed the patch of Carlson such that it has an ankle cover portion extending from a back heel portion to cover the skin surfaces of the inner and/or outer ankle in order to prevent pressure ulcers.
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carlson in view of U.S. Patent No. 5,135,473 (hereinafter Epler).
Regarding claim 23, Carlson discloses the apparatus of claim 21, except wherein the apparatus further comprises raised bead proximate the terminal edge of said back heel portion. However, Epler in an analogous device (10) teaches it is known to provide a bump (60) on a terminal edge of a back heel portion (see Fig. 4) in order to provide a counterforce perpendicular to the line of pull of the Achilles tendon. The bump also provides a moment arm through which stresses and forces normally placed on the Achilles tendon are dispersed (see col. 3, lines 52-61).
In view of Epler, it would have been obvious to one having ordinary skill in the art to have modified a patch of Carlson such that it includes a bump to be positioned a terminal edge of a back heel portion (see Fig. 4) in order to both provide a counterforce perpendicular to the line of pull of the Achilles tendon and to provide a moment arm through which stresses and forces normally placed on the Achilles tendon are dispersed.
Claim(s) 2, 25 and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carlson.
Regarding claim 2, Carlson discloses the apparatus of claim 1, except wherein (fr) is calculated as: fr=Fr/N, wherein Fr is the force of friction divided by N the normal or perpendicular force in Newtons pushing two objects together. However, Absent a critical teaching and/or a showing of unexpected results derived from the formula used to calculate the coefficient of friction, the Office contends that any standard formula used would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention.
Regarding claim 25, Carlsson discloses the apparatus of claim 24, except wherein said friction barrier generally is configured to generally conform to a combination of said plantar forefoot and a plantar midfoot of said human foot.
However, as can be seen from Fig. 1 and as can be read from col. 5, lines 41-44, the patches can be cut from composited sheet 10; and since the patches can be used on the human foot (see Fig. 10), it would have been obvious to one having ordinary skill in the art before the effective filing date of the presently claimed invention to have customized a patch such that it has a size that covers and generally conforms to a portion of the foot including a plantar forefoot and a plantar midfoot, depending upon the areas of the foot requiring reduction in shear trauma.
Regarding claim 26, modified Carlson discloses the apparatus of claim 25, except wherein said friction barrier generally configured to generally conform to a combination of said plantar forefoot, said plantar midfoot, and a heel of said human foot.
However, as can be seen from Fig. 1 and as can be read from col. 5, lines 41-44, the patches can be cut from composited sheet 10; and since the patches can be used on the human foot (see Fig. 10), it would have been obvious to one having ordinary skill in the art before the effective filing date of the presently claimed invention to have customized a patch such that it has a size that covers and conforms to said plantar forefoot, said plantar midfoot, and a heel of said human foot depending upon the areas of the foot requiring reduction in shear trauma.
Claim(s) 1, 4, 5, 9, 11 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 4,518,643 (“hereinafter Francis) as evidenced by Product Data Sheet for Polyethylene film (herein after Boralis) and in view of Ultra High Molecular Weight Polyethylene (hereinafter UHMW).
Regarding claim 1, Francis discloses a plastic film that discloses Applicant’s presently claimed invention. More specifically, Francis discloses a blister prevention apparatus (constituted by plastic film 10/90, see Fig. 1 and Fig. 6, which may be a single layer, see the abstract), comprising: a friction barrier (constituted by a single layer of film 10/90, see Figs. 1 and Fig. 6, the abstract and col. 4, lines 23-29 and col. 5, lines 39-40) adapted to position between a support surface and a skin surface (the plastic film of Francis is fully capable of accomplishing the intended use recitation of being positioned between a support surface and skin surface), wherein said friction barrier comprises a generally flat sheet material generally conformable by placement between said support surface and said skin surface, or a pre-formed material (a sheet of film 90) adapted to be placed between said support surface and said skin surface, wherein said friction barrier has first side adapted to face said skin surface having a static coefficient of friction (fr) of less than 0.2 (the sheet of film is constructed from polyethylene film having a coefficient of friction less than 0.2, see claim 9 and page 2 of Borealis which discloses the coefficient of friction of polyethylene film is 0.1)
Francis fails to disclose wherein said friction barrier comprising a compound, said compound selected from a group of compounds consisting of polyoxymethylene copolymer, polyoxymethylene homopolymer, polyethylene terephthalate, high-density polyethylene, ultra-high molecular weight polyethylene, polytetrafluoroethylene, fluorinated ethylene propylene, perfluoroalkoxy alkane, and combinations thereof; and wherein anyone of said compounds in said group being selectable as said compound.
However, UMHW teaches is known to provide ultra-high molecular weight polyethylene with a coefficient of friction of 0.08-0.2. Further, it has been held that the selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945) See also In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960)
In view of UHMW, it would have been prima facie obvious to one having ordinary skill in the art to have selected ultra-high molecular weight polyethylene for the polyethylene film of Frances film because of its low coefficient of friction allowing.
Regarding claim 4, Francis discloses the apparatus of claim 1, wherein said friction barrier has a second side (the side shown in Fig. 6) adapted to face said support surface, said second side including raised surface elements (protuberances in the form of truncated cones 91, see col. 5, lines 39-41).
Regarding claim 5, Francis discloses the apparatus of claim 4, wherein said raised surface elements configured to resist movement of said second side relative to said support surface (the protuberances are create a relatively rough side, which increases the resistance to movement of the surface upon which it is placed).
Regarding claim 9, Francis, as evidenced by Borealis, discloses the apparatus of claim 1, wherein said generally flat sheet material generally conformable by placement between said support surface and said skin surface or said pre-formed material adapted to be placed between said support surface and said skin surface (as discussed in the rejection of claim 1 above), comprises a plurality of layers (10, 20, see Figs. 1 and wherein a first layer (10) including said first side is adapted to face said skin (the outer face of 10 is fully capable of facing skin), and wherein a second layer (20) including a second side is adapted to face said support surface (the outer face of the film 20 is capable of facing a support surface), wherein said first layer adapted to face said skin surface having said static coefficient of friction of less than 0.2 (film layer 10 is constructed from polyethylene film having a coefficient of friction less than 0.2, see claim 9 and page 2 of Borealis which discloses the coefficient of friction of polyethylene film is 0.1).
Regarding claim 11, Frances, as evidenced by Borealis, discloses the apparatus of claim 9, wherein said first layer and said second layer each comprise a separate discrete layer (see Figs. 1 and 3).
Regarding claim 12, Frances, as evidenced by Borealis, discloses the apparatus of claim 11, wherein said first layer slidably engages said second layer (see Fig. 1, see col. 4, lines 42-48).
Allowable Subject Matter
Claim 13 is allowed.
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 KIM M LEWIS whose telephone number is (571)272-4796. The examiner can normally be reached Monday -Friday 5:30 am -11:30 am.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alireza Nia can be reached at (571)270-3076. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KIM M LEWIS/Primary Examiner, Art Unit 3786