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 .
Election/Restrictions
Claims 1-11, 16, and 18-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/10/2025.
Response to Amendment
Applicant’s amendments of claims 12-15, and 17 are acknowledged by the Examiner.
Applicant’s cancelation of withdrawn claims 1-11, 16, and 18-19 are acknowledged by the Examiner.
Applicant’s addition of new claim 20 is acknowledged by the Examiner.
Claims 12-15, 17, and 20 are pending in the application.
Claim Objections
Claims 12-15, 17, and 20 are objected to because of the following informalities:
Claim 12 contains 7 recitations of “three dimensional”. These recitations should be amended to recite “three-dimensional”.
Claims 13-15, 17, and 20 should each be amended to include a comma to separate the preamble and body of the claims.
Claim 14 recites the limitation “arranged to conform”. This limitation should be amended to recite “configured to conform”.
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 13 and 17 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 13 recites the limitation “selecting each of the ventilation members” which implies selecting more than one ventilation member. This limitation is unclear in view of claim 12 which recites one or more ventilation members. Thus, it is unclear as to how multiple ventilation members can be selected in the embodiments with one ventilation member. For the purpose of examination, Examiner will interpret this limitation as “selecting the one or more ventilation members”.
Claim 17 recites the limitation “bonding each of the ventilation members” which implies selecting more than one ventilation member. This limitation is unclear in view of claim 12 which recites one or more ventilation members. Thus, it is unclear as to how multiple ventilation members can be bonded in the embodiments with one ventilation member. For the purpose of examination, Examiner will interpret this limitation as “bonding the one or more ventilation members”.
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) 12-15, and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barberio (US 2004/0162511 A1) (hereinafter Barberio ‘511), in view of Barberio (US 2007/0171749 A1) (hereinafter Barberio ‘749), and Barberio (WO 2019/126875 A1) (hereinafter Barberio ‘875).
In regards to claim 12, Barberio ‘511 discloses A method for forming a total contact cast (see figures 3-4) to treat a wound on a patient's leg comprising (see [0006]; an area of “dressed skin” is for treating a wound):
applying a wound dressing (thin breathable cloth or jersey material; see [0011]) to the wound (see [0011]);
after applying the wound dressing, covering the patient's leg with a stockinette (stockingnette; see [0082]);
after covering the patient's leg with a stockinette, mounting to the stockinette:
one or more ventilation members (1; see [0083]; see figure 2) respectively comprising three dimensional fabric spacer material (2; see [0083]; see figure 2; 22 of 2 is fabric and thus, 2 which comprises 13 and 22, is a three dimensional fabric spacer material) and which are mounted to the stockinette in a manner covering both dorsal and frontal areas thereof (see figure 3 that 2 covers both dorsal and frontal areas of the leg; and thus, covers frontal and dorsal areas of the stockingnette applied over the leg); and
after mounting said one or more ventilation members (1), applying a cast material (8; see [0098]; see figure 4) thereover in a substantially encapsulating fashion leaving upper extremities of the one or more ventilation members exposed (see figure 4) for admission of ambient air into three dimensional fabric spacer material (2; see figures 5-6), while enabling absorbative relief of edema pressure, at areas covered by the cast material, by exploiting a compressibility of the three dimensional fabric spacer material (see [0017] in reference to the fabric having elasticity and substantially tubular configuration; this elasticity, and consequential compressibility of the tubes under the elastic fabric enables absorbative relief of edema pressure, at areas covered by the cast material as claimed);
wherein said mounting of said one or more ventilation members (1) to the stockinette (stockingnette) comprises applying a dorsal portion of said three dimensional fabric spacer material in a position reaching down to a heel of the stockinette (see figure 5) and past the sole of the foot of the user (See figure 3).
Barberio ‘511 does not disclose mounting to the stockinette:
a perforated sole, which is mounted to a plantar area of the stockinette, and is accompanied by attached placement of a protruded base in a position that underlies the perforated sole, said protruded base having raised protrusions on a topside thereof and open gaps between said protrusions that fluidically communicate with holes in the perforated sole to cooperatively enable airflow therethrough to a plantar region of the patient's foot;
said three dimensional fabric spacer material comprising a sandwiched arrangement of first and second fabric sheets with a webbed layer of yarn or thread that resides between, and flexibly interconnects, said first and second fabric sheets, which webbed layer is fluidically open to enable airflow therethrough between said first and fabric sheets, and is also compressible in a thickness direction in which said first and second fabric sheets are separated by said webbed layer;
after mounting said perforated sole and said protruded base, applying a cast material thereover; and
applying a dorsal portion of said three dimensional fabric spacer material in a position reaching down to a heel of the stockinette and past the perforated sole to the protruded base, where the three dimensional fabric spacer material feeds fluidically into the gaps of the protruded base such that said airflow through the three dimensional fabric spacer material ultimately reaches the plantar region of the patient's foot through the gaps of the protruded base and the holes of the perforated sole.
However, Barberio ‘749 teaches an analogous method for forming a total cast (202; see [abstract]; see [0056]; see figure 11) comprising an analogous ventilation member (266’; see [0068]; see figure 14); further comprising a perforated sole (256’ which is porous; see [0068]; see figure 14), which is mounted to a plantar area of the foot (see figure 14), and is accompanied by attached placement of a protruded base (244’; see [0068]; see figure 14) in a position that underlies the perforated sole (256’; see figure 14), said protruded base (244’) having raised protrusions on a topside thereof and open gaps between said protrusions that fluidically communicate with holes in the perforated sole (256’) to cooperatively enable airflow therethrough to a plantar region of the patient's foot (see [0068] in reference to air pathways 252’ (considered similar to 66 seen in figure 2) permitting airflow to the patient’s foot);
after mounting said perforated sole (256’) and said protruded base (244’), applying a cast material (202) thereover (see figure 14); and
applying a dorsal portion of said three dimensional fabric spacer material (266’) in a position reaching down to a heel of the user and past the perforated sole (256’) to the protruded base (244’; see figure 14 that 298 reaches 244’ as claimed), where the three dimensional fabric spacer material (266’) feeds fluidically into the gaps (252’) of the protruded base (244’) such that said airflow through the three dimensional fabric spacer material (266’) ultimately reaches the plantar region of the patient's foot through the gaps (252’) of the protruded base (244’) and the holes of the perforated sole (256’; see [0068]) for the purpose of providing ventilation to the skin of the user’s foot enclosed within the cast material to alleviate discomfort and irritation to the skin (see [0004]) while also providing firm support to a major portion of the user’s foot (see [0013]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method for forming a total contact cast as disclosed by Barberio ‘511 and to have included the step of mounting a perforated sole, and a protruded base prior to applying a cast material as taught by Barberio ‘749 in order to have provided an improved method for forming a total contact cast that would add the benefit of providing ventilation to the skin of the user’s foot enclosed within the cast material to alleviate discomfort and irritation to the skin (see [0004]) while also providing firm support to a major portion of the user’s foot (see [0013]).
Barberio ‘511 as now modified by Barberio ‘749 still does not disclose said three dimensional fabric spacer material comprising a sandwiched arrangement of first and second fabric sheets with a webbed layer of yarn or thread that resides between, and flexibly interconnects, said first and second fabric sheets, which webbed layer is fluidically open to enable airflow therethrough between said first and fabric sheets, and is also compressible in a thickness direction in which said first and second fabric sheets are separated by said webbed layer.
However, Barberio ‘875 teaches an analogous method for forming a total contact cast (see [0050]) comprising an analogous at least one ventilation member (12000; see [0067]; see figure 12) respectively comprising three dimensional fabric spacer material (see [0067]); said three dimensional fabric spacer material comprising a sandwiched arrangement of first and second fabric sheets (12110 and 12120; see [0067]; see figure 12) with a webbed layer of yarn or thread (12130; see [0067]; see figure 12) that resides between, and flexibly interconnects, said first and second fabric sheets (see figure 12), which webbed layer is fluidically open to enable airflow therethrough between said first and fabric sheets (see [0067]), and is also compressible in a thickness direction in which said first and second fabric sheets are separated by said webbed layer (see [0065]) for the purpose of providing one or more ventilation members which are capable of being compressed (see [0065]) while also allowing for free air movement through the ventilation member (see [0067]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the one or more ventilation members as disclosed by Barberio ‘511 and to have formed the one or more ventilation members from the sandwiched arrangement of first and second fabric layers, interconnected by a webbed layer as taught by Barberio ‘875 in order to have provided an improved one or more ventilation members that would add the benefit of providing one or more ventilation members which are capable of being compressed (see [0065]) while also allowing for free air movement through the ventilation member (see [0067]).
In regards to claim 13, Barberio ‘511 as now modified by Barberio ‘749 and Barberio ‘875 discloses the invention as discussed above.
Barberio ‘511 as now modified by Barberio ‘875 further discloses wherein said mounting of said one or more ventilation members (1 of Barberio ‘511 as now modified by Barberio ‘875) to the stockinette (stockingnette of Barberio ‘511) comprises selecting each of the ventilation members (1 of Barberio ‘511 as now modified by Barberio ‘875) from a prefabricated set having a common shape arranged to conform to a prescribed portion of the patient's leg and different dimensions (see Barberio ‘875 [0064-0065] in reference to the common shape, and how the ventilation members are arranged to conform to the patient’s limbs and different dimensions).
In regards to claim 14, Barberio ‘511 as now modified by Barberio ‘749 and Barberio ‘875 discloses the invention as discussed above.
Barberio ‘511 further discloses wherein said mounting of said one or more ventilation members (1) to the stockinette (stockingnette) comprises mounting at least one of said one or more ventilation members (1) in a stretched condition over portions of the patient's leg (see [0104] in reference to stretching 22 of 1 over the user’s limb).
In regards to claim 15, Barberio ‘511 as now modified by Barberio ‘749 and Barberio ‘875 discloses the invention as discussed above.
Barberio ‘511 further discloses wherein said mounting of said one or more ventilation members (1) to the stockinette (stockingnette) comprises respectively aligning said one or more ventilation members relative to the patient's leg using a first adhesive portion (114; see [0127]; see figure 26; 114 is attached via adhesive and thus is an “adhesive portion) at one end of a respective one of the ventilation members (see figure 26) and, after aligning, respectively securing said one or more ventilation members (1) using a second adhesive portion (see [0081] in reference to the padding comprising adhesive for adhering to the stockingnette) covering a larger surface area (see [0011] that the padding may be affixed to significant portions of the aerating devices) of the respective ventilation member than the first adhesive portion (114; see figure 26; the area where 114 binds to the ventilation members smaller than the area of 330 (applied on significant portions of the aerating device); thus, the area of the second adhesive portion is larger than the area of the first adhesive portion).
In regards to claim 15, Barberio ‘511 as now modified by Barberio ‘749 and Barberio ‘875 discloses the invention as discussed above.
Barberio ‘511 further discloses wherein said mounting of said one or more ventilation members (1) to the stockinette (stockingnette) comprises bonding each of the ventilation members to the stockinette (see [0082] in reference to adhesively bonding the padding of the ventilation member to the stockingnette).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barberio ‘511 in view of Barberio ‘749, and Barberio ‘875 as applied to claim 12 above, and further in view of Liebmann (US 2001/0001412 A1).
In regards to claim 20, Barberio ‘511 as now modified by Barberio ‘749 and Barberio ‘875 discloses the invention as discussed above.
Barberio ‘511 further discloses wherein said one or more ventilation members (1) have pre-applied adhesive thereon (adhesive on 330 for bonding the ventilation member to the stockingnette; see [0082]),
Barberio ‘511 as now modified by Barberio ‘749 and Barberio ‘875 does not disclose which pre-applied adhesive is initially covered by one or more pre-applied release liners, and the mounting of the one or more ventilation members to the stockinette comprises removing said one or more pre-applied release liners and bonding said pre-applied adhesive to the stockinette.
However, Liebmann teaches an analogous garment (10; see [0022]; see figure 1) comprising an analogous pre-applied adhesive thereon (14; see [0037]; see figure 4); which pre-applied adhesive (14) is initially covered by one or more pre-applied release liners (12; see [0037]; see figure 5), and prior to mounting the garment (10), removing said one or more pre-applied release liners (12) and bonding said pre-applied adhesive (14; see [0037]) for the purpose of providing a protective layer for the pre-applied adhesive (see [0037]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the pre-applied adhesive of the ventilation members as disclosed by Barberio ‘511 as now modified by Barberio ‘749 and Barberio ‘875 and to have included the pre-applied release liner applied over the pre-applied adhesive, and the step of removing the pre-applied release liner from the pre-applied adhesive prior to mounting the pre-applied adhesive to the intended structure as taught by Liebmann in order to have provided an improved one or more ventilation members that would add the benefit of providing a protective layer for the pre-applied adhesive (see [0037]) thereby ensuring the pre-applied adhesive of the one or more ventilation members would be protected and tacky until application.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL MILLER whose telephone number is (571)270-5445. The examiner can normally be reached Mon-Fri 8am-4pm.
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/DANIEL A MILLER/Primary Examiner, Art Unit 3786