DETAILED CORRESPONDENCE
Note: This office action is in response to communication filed on 04/07/2026.
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 .
Status of Claims
Claims 1-3, 5, 8, 10-11, 13-17, 20-21, 23, 27-28, 30-32, and 35 are pending in the application.
Claims 11, 13-17, 20-21, 23, 27-28, 30-32, and 35 are withdrawn from further consideration
Claims 1-3, 5, 8, and 10 are examined on the merits.
Response to Arguments
Applicant’s arguments filed on 04/07/2026 have been fully considered, but are moot because the independent claim(s) has/have been amended the new ground of rejection relies on a different interpretation of the previously applied art for any teaching or matter specifically challenged in the argument.
Applicant argues that Lucas does not teach or suggest “an adhesive configured to seal a first longitudinal section of the occlusive layer to a second longitudinal section of the occlusive layer when the decompression wrap is spiral wrapped around a tissue site” because the manifold layer 106 has to change position relative to the occlusive layer 102 in order to achieve the claimed feature. Applicant’s arguments are not found persuasive. First, Applicant is setting forth the intend use of the claimed apparatus, which does not add patentable weight to the structural limitations of the wrap (See MPEP 2114 (II) and 2115). The wrap of Lucas is capable of sealing a first longitudinal section of the occlusive layer to a second longitudinal section of the occlusive layer when the decompression wrap is spiral wrapped around a tissue site. Second, since the apparatus of the prior art of record and the claimed apparatus are patentably indistinct in terms of structure, the wrap of Lucas is expected to be capable of wrapping around a tissue site (MPEP 2112.01 (I) and 2114 (I)-(II)).
With respect to the drawing objection(s), applicant’s amendment(s) to the claim(s) has/have overcome the objection(s).
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 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) 1 and 10 is/are rejected under 35 U.S.C 103 as being unpatentable over Lucas (US PAT 6362388 – of record) in view of Sanders (US PGPUB 20050020955 – of record).
Regarding claim 1, Lucas discloses a decompression wrap (a wrap or an adhesive bandage that is used for treating wounds: Col. 5, line 55 – Col. 6, line 17 and Fig. 20; thus, the wrap or adhesive bandage is capable of being used as a decompression wrap), comprising:
an occlusive layer formed as a first strip (a carrier strip 102: Col. 3, lines 20-25; and Fig. 20) having a longitudinal axis (see annotated Fig. 20 below);
a layer coupled to the occlusive layer (a dressing element 106: Col. 4, lines 50-55 and Fig. 20) and formed as a second strip extending parallel to the longitudinal axis (Fig. 20), wherein the occlusive layer extends beyond the manifold layer in a second lateral direction perpendicular to the longitudinal axis (the occlusive layer 102 extends beyond the layer 106 in a second lateral direction perpendicular to the longitudinal axis: see annotated Fig. 20 below), and wherein the manifold layer extends beyond the occlusive layer in a first lateral direction opposite the second lateral direction (when the wrap of Lucas is wrapped around a tissue site, the manifold layer of Lucas is capable of extending beyond the occlusive layer in a first lateral direction opposite the second lateral direction); and
an adhesive provided on the occlusive layer (adhesive portions 154: Col. 4, lines 50-63 and Fig. 20) and configured to seal a first longitudinal section of the occlusive layer to a second longitudinal section of the occlusive layer when the decompression wrap is spiral wrapped around a tissue site (Applicant is setting forth the intend use of the claimed apparatus, which does not add patentable weight to the structural limitations of the wrap (See MPEP 2114 (II) and 2115); The wrap of Lucas is capable of sealing a first longitudinal section of the occlusive layer to a second longitudinal section of the occlusive layer when the decompression wrap is spiral wrapped around a tissue site).
Lucas further discloses the adhesive is exposed on the occlusive layer beyond the manifold layer in the second lateral direction (the adhesive is exposed along the entire length of the layer 102: Col. 4, lines 50-63 and see annotated Fig. 20 below).
In the embodiment of Fig. 20, Lucas does not disclose the adhesive is positioned and exposed on a patient-facing surface of at least one longitudinal end of the occlusive layer that extends beyond the manifold layer parallel to the longitudinal axis and in a longitudinal direction perpendicular to the second lateral direction such that the adhesive is exposed on the occlusive layer beyond the manifold layer in both the longitudinal direction and the second lateral direction. In the embodiment of Figs. 8-10, Lucas suggests to have a segment of adhesive material 130 attached to the back side of the occlusive layer 102 for the benefit of preventing the wrap from uncoiling and securing the wrap to a back side 128 of the wrap (Col. 3, line 49 – Col. 4, line 5). From these teachings, a person having ordinary skill in the art would have recognized/deduced that having the adhesive positioned and exposed on a patient-facing surface of at least one longitudinal end of the occlusive layer that extends beyond the manifold layer parallel to the longitudinal axis and in a longitudinal direction perpendicular to the second lateral direction such that the adhesive is exposed on the occlusive layer beyond the manifold layer in both the longitudinal direction and the second lateral direction yields the predictable result of preventing the wrap from uncoiling and securing the wrap to a back side 128 of the wrap.
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the wrap of Lucas of the embodiment of Fig. 20 with the embodiment of Figs. 8-10 by having the adhesive exposed on the occlusive layer beyond the manifold layer in both the longitudinal direction and the second lateral direction, in order to prevent the wrap from uncoiling and secure the wrap to a back side of the wrap, as suggested in Col. 3, line 49 – Col. 4, line 5 of Lucas and as it has been held that the use of known technique to yield predictable result is prima facie obvious. See MPEP § 2143 (I) (C & G).
Lucas does not disclose the layer coupled to the occlusive layer is a manifold layer.
In the same field of endeavor, a wrap for placement over a wound on an extremity, Sanders discloses an occlusive wrapping 10 comprising an occlusive layer 16 (¶0023 and Fig. 1A). Sanders further teaches to have a manifold layer (a fluid manifold 14: ¶0023 and Fig. 1A) coupled to the occlusive layer 16 for the benefit of enhancing fluid communication between layers of the wrap (¶0023).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the wrap of Lucas in view of Sanders by selecting a manifold as a dressing element coupled to the occlusive layer, in order to enhance fluid communication between layers of the wrap, as suggested in ¶0023 of Sanders and as it has been held that the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination (See MPEP § 2144.07).
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Regarding claim 10, Lucas in view of Sanders discloses all the limitations as discussed above for claim 1.
Lucas/Sanders does not disclose the manifold layer is configured to collapse toward the occlusive layer when a negative pressure is established at the manifold layer; however, a person having ordinary skill in the art would have understood/recognized that the manifold layer is made of a porous foam material and is configured to collapse when a negative pressure is applied. Thus, the manifold layer of Lucas in view of Sanders is capable of collapsing toward the occlusive layer when a negative pressure is established at the manifold layer
Claim(s) 2-3 is/are rejected under 35 U.S.C 103 as being unpatentable over Lucas (US PAT 6362388 – of record) in view of Sanders (US PGPUB 20050020955 – of record), as applied to claim 1 above, and further in view of McGuire (US PGPUB 20120101465).
Regarding claim 2, Lucas in view of Sanders discloses all the limitations as discussed above for claim 1.
Lucas/Sanders discloses the occlusive layer extends beyond the manifold layer in the second lateral direction (see rejection of claim 1 above).
Lucas further discloses/suggests that the dimensions of the occlusive layer and the dressing element would be sized in accordance with the particular application (Col. 6, lines 3-5), but Lucas/Sanders does not disclose the occlusive layer extends beyond the manifold layer in the second lateral direction by less than ten centimeters.
In the same field of endeavor, decompression wrap, McGuire discloses a roll of a wound dressing 10 comprising an adhesive layer 12 and an elastic layer 14 (¶0053 and Fig. 1). McGuire further teaches the elastic layer 14 has a width of less than 10 cm (¶0037: a width of 5 cm to 10 cm; thus, the taught width is within the claimed range width) for the benefits of forming an effective bond, displacing excess moisture as it is wound around itself, and maintaining desired adhesion and wound compression (¶0022).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the wrap of Lucas/Sanders in view of McGuire by having/making the occlusive layer extends beyond the manifold layer in the second lateral direction by less than ten centimeters, in order to form an effective bond, displace excess moisture as it is wound around itself, and maintain desired adhesion and wound compression, as suggested in ¶0022 of McGuire and since it has been held that scaling up or down of an element which merely requires a change in size is generally considered as being within the ordinary skill in the art ((See MPEP § 2144.04 (IV) (A)). Further, Applicant places no criticality on the dimension claimed, indicating simply that the occlusive layer extends beyond the manifold layer in the second lateral direction by less than ten centimeters (¶0005 and 0042).
Regarding claim 3, Lucas in view of Sanders discloses all the limitations as discussed above for claim 1.
Lucas/Sanders discloses the occlusive layer extends beyond the manifold layer in the second lateral direction (see rejection of claim 1 above).
Lucas further discloses/suggests that the dimensions of the occlusive layer and the dressing element would be sized in accordance with the particular application, but Lucas/Sanders does not disclose the occlusive layer extends beyond the manifold layer in the second lateral direction by a distance in a range between two centimeters and five centimeters.
McGuire further teaches the elastic layer 14 has a width in a range between 2 cm and 5 cm (¶0037: a width of 5 cm to 10 cm; thus, the taught width overlaps the claimed range width) for the benefits of forming an effective bond, displacing excess moisture as it is wound around itself, and maintaining desired adhesion and wound compression (¶0022).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the wrap of Lucas/Sanders in view of McGuire by having/making the occlusive layer extends beyond the manifold layer in the second lateral direction by a distance in a range between two centimeters and five centimeters, in order to form an effective bond, displace excess moisture as it is wound around itself, and maintain desired adhesion and wound compression, as suggested in ¶0022 of McGuire and since it has been held that scaling up or down of an element which merely requires a change in size is generally considered as being within the ordinary skill in the art ((See MPEP § 2144.04 (IV) (A)). Further, Applicant places no criticality on the dimension claimed, indicating simply that the occlusive layer extends beyond the manifold layer in the second lateral direction by a distance in a range between two centimeters and five centimeters (¶0005 and 0042).
Claim(s) 5 is/are rejected under 35 U.S.C 103 as being unpatentable over Lucas (US PAT 6362388 – of record) in view of Sanders (US PGPUB 20050020955 – of record), as applied to claim 1 above, and further in view of Bourdillon (US PGPUB 20200197559).
Regarding claim 5, Lucas in view of Sanders discloses all the limitations as discussed above for claim 1.
Lucas further discloses the occlusive layer is air-impermeable (Col. 5, lines 52-54).
Lucas/Sanders does not disclose the manifold layer comprises an open-celled foam.
In an analogous art for being directed to solve the same problem, improving distribution and/or collection of fluids, Bourdillon discloses a wound dressing 110 comprising a tissue interface 115 and a cover 120 (¶0075 and Fig. 1). Bourdillon further teaches open-cell foam is a suitable material for use as a manifold material (¶0082) for the benefit of improving distribution and/or collection of fluids (¶0082).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the manifold layer of Lucas/Sanders in view of Bourdillon by selecting open-cell foam as a material, in order to improve distribution and/or collection of fluids, as suggested in ¶0082 of Bourdillon and as it has been held that the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination (See MPEP § 2144.07). Further, one would have been motivated to select the material of open-cell foam to be the manifold layer for the purpose of improving distribution and/or collection of fluids.
Claim(s) 8 is/are rejected under 35 U.S.C 103 as being unpatentable over Lucas (US PAT 6362388 – of record) in view of Sanders (US PGPUB 20050020955 – of record), as applied to claim 1 above, and further in view of Murphy (US PGPUB 20080014387).
Regarding claim 8, Lucas in view of Sanders discloses all the limitations as discussed above for claim 1.
Lucas/Sanders does not disclose a patient interface layer coupled to the manifold layer such that the manifold layer is positioned between the patient interface layer and the occlusive layer.
In an analogous art for being directed to solve the same problem, wicking fluid from the wound site, Murphy discloses a bandage 30 comprising a foam layer 24, a baking layer 22 and a web adhesive 25 (¶0034 and Fig. 5). Murphy further teaches to have a patient interface layer (a wound care pad 20: ¶0034 and Fig. 5) coupled to the foam layer 24 via the web adhesive 25 (Fig. 5) for the benefits of transporting fluid and providing wicking of fluids from the wound site (¶0113).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the wrap of Lucas/Sanders in view of Murphy by incorporating a patient interface layer coupled to the manifold layer such that the manifold layer is positioned between the patient interface layer and the occlusive layer, in order to transport fluid and provide wicking of fluids from the wound site, as suggested in ¶0113 of Murphy.
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 NHU Q TRAN whose telephone number is (571)272-2032. The examiner can normally be reached Monday-Thursday 8:00-5:00 (PST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, SARAH AL-HASHIMI can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NHU Q. TRAN/Examiner, Art Unit 3781
/SARAH AL HASHIMI/Supervisory Patent Examiner, Art Unit 3781
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