DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Arguments
Applicant’s amendment, filed 07/16/2026, is accepted and entered.
Applicant's arguments filed 07/16/2026 have been fully considered but they are not persuasive.
Applicant alleges that Cavanaugh does not disclose the notch in the perimeter of the material layer, where the slit is in the perimeter, which is in the plane including the central longitudinal axis and the transverse axis. However, this is not found persuasive as at least a portion of the perimeter of the bolster of Cavanaugh is within the plane including the central longitudinal axis and the transverse axis, and therefore at least a portion of the slit is within the perimeter in the plane.
Applicant further alleges that Cavanaugh does not disclose the at least one notch configured to alter the shape of the perimeter of the material layer in the plane. However, due to the amendments to the claims, the scope of this limitation has changed as the at least one notch is also v-shaped. Masini teaches v-shaped notches that are configured to alter the shape of the perimeter of the material layer in the plane, as set forth below.
Additionally, Cavanaugh/Aali is no longer cited to disclose the notches going through the entire thickness of the material layer. The slits of Cavanaugh are now substituted for the notches of Masini, which would result in each slit becoming a v-shaped notch that goes through the entire thickness of the dressing. This would not result in severing the material, as each perimeter slit would be substituted for a perimeter v-shaped notch, and this would not result in a complete cut through the layer as the center of the layer would not be affected.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 114-119, 121, 124, and 126-135 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Cavanaugh et al (US 2009/0299342) in view of Masini (US 6599262).
Regarding Claims 114 and 134, Cavanaugh discloses a negative pressure wound therapy apparatus (1010, Fig. 15) comprising:
a wound dressing (1030, Fig. 15) having a thickness, a length, a width, a central longitudinal axis (see Image 1) extending along the length and a transverse axis (see Image 1) extending along the width perpendicular to the central longitudinal axis (see Image 1), the central longitudinal axis and the transverse axis in a plane, the wound dressing (1030, Fig. 15) comprising:
a wound contact layer (second drape portion 1065, Fig. 15) configured to be positioned over skin surrounding a wound (¶ [0078]);
a material layer (bolster 1032, Fig. 15) positioned above the wound contact layer (1065, Fig. 15), the material layer (1032, Fig. 15) comprising a perimeter in the plane (see Image 1, Fig. 15; at least a portion of the perimeter is in the plane with the central longitudinal axis and the transverse axis);
a backing layer (first drape portion 1063, Fig. 15) above the material layer (1032, Fig. 15);
a port (¶ [0080]) coupled to an upper surface of the backing layer (1063, Fig. 15) on one side of the transverse axis, the port configured to connect the wound dressing to a source of negative pressure (¶ [0080]); and
at least one notch (1078, Fig. 15) in the perimeter of the material layer (1032, Fig. 15) configured to aid in conforming the wound dressing (1030, Fig. 15) to a nonplanar wound (¶ [0073, 0077]).
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Image 1: Annotated Partial Fig. 15 of Cavanaugh
Cavanaugh is silent whether the at least one notch is v-shaped, the notch forming a gap in the perimeter at a base of the v-shape, the notch extending through the entire thickness of the material layer, wherein the at least one notch is configured to alter the shape of the perimeter of the material layer in the plane, and wherein the at least one v-shaped notch comprises a plurality of v-shaped notches in the perimeter.
Masini teaches a wound dressing, thus being in the same field of endeavor, with a plurality of v-shaped notches (608, Fig. 6B; Col. 6 lines 34-56) in the perimeter of the material layer (as seen in Fig. 6B), the notches (608, Fig. 6B) forming a gap in the perimeter at a base of the v-shape (as seen in Fig. 6B), the notches (608, Fig. 6B) extending through the entire thickness of the material layer (as seen in Fig. 6B; Col. 6 lines 34-56) to configured to aid in conforming the wound dressing to a nonplanar wound (Col. 6 lines 34-56). The v-shaped notches are configured to alter the shape of the perimeter of the material layer in the plane, as seen in Fig. 6B, since the perimeter of the layer is modified by the presence of the v-shaped gaps formed by the notches.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the notches of Cavanaugh for the plurality of v-shaped notches of Masini, the notches forming a gap in the perimeter at a base of the v-shape, the notches extending through the entire thickness of the material layer, and wherein the at least one notch is configured to alter the shape of the perimeter of the material layer in the plane, as taught by Masini. Masini indicates that the v-shaped notches improve the flexibility of the dressing, and therefore one of ordinary skill in the art would find it obvious to substitute linear notches for v-shaped notches, as v-shaped notches are shown by Masini to be known in the art for improving the flexibility of wound dressings on non-planar patient surfaces or in the event of a curved wound or incision (as motivated by Masini Col. 6 lines 34-56).
Regarding Claim 115, Cavanaugh further discloses the material layer (1032, Fig. 15) comprises:
a first portion (portion of bolster on side B of transverse axis, as seen in Image 1) positioned on one side of the transverse axis, the first portion comprising side surfaces on opposite sides of the central longitudinal axis (as seen in Image 1); and
a second portion (portion of bolster on side A of transverse axis, as seen in Image 1) positioned on an opposite side of the transverse axis, wherein the at least one notch (1078, Fig. 15) comprises a first notch between the first and second portions and a second notch between the first and second portions (the lateral notch 1078 covered by the transverse axis in Image 1 can be interpreted as two notches that are divided by the notch along the central longitudinal axis; these two notches would be between the first and second portions).
Regarding Claim 116, Cavanaugh further discloses each side surface of the first portion (portion of bolster on side B of transverse axis, as seen in Image 1) comprises a substantially straight portion (each side surface is substantially straight before curving at the end, as seen in Image 1).
Regarding Claim 117, Cavanaugh further discloses each side surface of the first portion (portion of bolster on side B of transverse axis, as seen in Image 1) comprises a convex curve (each side surface ends in a convex curve, where the ends of both convex curves meet, as seen in Image 1).
Regarding Claim 118, Cavanaugh further discloses at least one additional notch (1078, Fig. 15) in at least one of the convex curves in at least one of the side surfaces (the notch under the central longitudinal axis can be considered in both of the convex curves of both side edges as this is where the convex curves meet, as seen in Image 1).
Regarding Claim 119, Cavanaugh further discloses the first notch and the second notch are located on the transverse axis (the lateral notch 1078 covered by the transverse axis in Image 1 can be interpreted as two notches that are divided by the notch along the central longitudinal axis; these two notches would be between the first and second portions).
Regarding Claim 121, Cavanaugh further discloses the material layer (1032, Fig. 15) comprises:
a first portion (portion of bolster on side B of transverse axis, as seen in Image 1) positioned on one side of the transverse axis, the first portion comprising the port (¶ [0080] indicates the port will be over the aperture 1081, which is on side B of the transverse axis as seen in Image 1) and side surfaces on opposite sides of the central longitudinal axis (as seen in Image 1); and
a second portion (portion of bolster on side A of transverse axis, as seen in Image 1) positioned on an opposite side of the transverse axis, the second portion comprising side surfaces (as seen in Image 1) and at least one of the at least one notches (1078, Fig. 15).
Regarding Claim 124, Cavanaugh further discloses at least a portion of the side surfaces of the second portion (portion of bolster on side A of transverse axis, as seen in Image 1) are substantially straight (each side surface is substantially straight before curving at the end, as seen in Image 1).
Regarding Claim 126, Cavanaugh further discloses the at least one notch comprises six notches along the perimeter of the material layer (1032, Fig. 15).
Regarding Claim 127, Cavanaugh further discloses the material layer (1032, Fig. 15) is symmetric about the central longitudinal axis (as seen in Image 1).
Regarding Claim 128, Cavanaugh further discloses the material layer (1032, Fig. 15) is symmetric about the transverse axis (as seen in Image 1).
Regarding Claim 129, Cavanaugh further discloses the material layer (1032, Fig. 15) comprises an absorbent material (¶ [0032]).
Regarding Claim 130, Cavanaugh further discloses the material layer (1032, Fig. 15) comprises foam (¶ [0031-0032]).
Regarding Claim 131, Cavanaugh further discloses adhesive on the wound contact layer (1065, Fig. 15) configured to adhere the wound contact layer (1065, Fig. 15) with the backing layer (1063, Fig. 15) to the skin surrounding the wound (¶ [0078]).
Regarding Claim 132, Cavanaugh further discloses the backing layer (1063, Fig. 15) is larger than the material layer (1032, Fig. 15).
Regarding Claim 133, Cavanaugh further discloses the perimeter of the backing layer (1063, Fig. 15) does not include a notch (as seen in Fig. 15).
Regarding Claim 135, Cavanaugh discloses a negative pressure wound therapy apparatus (1010, Fig. 15) comprising:
a wound dressing (1030, Fig. 15) having a thickness, a length, a width, a central longitudinal axis (see Image 1) extending along the length and a transverse axis (see Image 1) extending along the width perpendicular to the central longitudinal axis (see Image 1), the central longitudinal axis and the transverse axis in a plane, the wound dressing (1030, Fig. 15) comprising:
a wound contact layer (second drape portion 1065, Fig. 15) configured to be positioned over skin surrounding a wound (¶ [0078]);
a material layer (bolster 1032, Fig. 15) positioned above the wound contact layer (1065, Fig. 15), the material layer (1032, Fig. 15) comprising a perimeter in the plane (see Image 1, Fig. 15; at least a portion of the perimeter is in the plane with the central longitudinal axis and the transverse axis), and wherein the material layer (1032, Fig. 15) is symmetric about the central longitudinal axis and symmetric about the transverse axis (as seen in Image 1);
a backing layer (first drape portion 1063, Fig. 15) above the material layer (1032, Fig. 15);
a port (¶ [0080]) coupled to an upper surface of the backing layer (1063, Fig. 15) on the central longitudinal axis and on one side of the transverse axis (¶ [0080] indicates the port is connected to the “aperture 1082” in drape 1063; ¶ [0078] refers to aperture 1081, which is present in Fig. 15; the aperture 1081 is on the central longitudinal axis and on one side of the transverse axis as seen in Image 1, so the port will also be on the central longitudinal axis and on one side of the transverse axis), the port configured to connect the wound dressing to a source of negative pressure (¶ [0080]); and
at least four notches (1078, Fig. 15) symmetrically provided along opposite sides of the central longitudinal axis in the perimeter of the material layer (1032, Fig. 15) configured to aid in conforming the wound dressing (1030, Fig. 15) to a nonplanar wound (¶ [0073, 0077]), the notches (1078, Fig. 15) configured to aid in conforming the wound dressing to a nonplanar wound (¶ [0073, 0077]; the notches allow the bolster to flex and spread apart at the notches, including along the plane that contains both the transverse and central longitudinal axes, therefore allowing the shape to conform around a nonplanar wound).
Cavanaugh is silent whether the at least four notches are v-shaped, each v-shaped notch extending inward toward a center of the wound dressing, wherein the notches extending through the entire thickness of the material layer.
Masini teaches a wound dressing, thus being in the same field of endeavor, with at least four v-shaped notches (608, Fig. 6B; Col. 6 lines 34-56) in the perimeter of the material layer (as seen in Fig. 6B), the notches (608, Fig. 6B) extending inward toward a center of the wound dressing (as seen in Fig. 6B), the notches (608, Fig. 6B) extending through the entire thickness of the material layer (as seen in Fig. 6B; Col. 6 lines 34-56) to configured to aid in conforming the wound dressing to a nonplanar wound (Col. 6 lines 34-56).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the notches of Cavanaugh for the plurality of v-shaped notches of Masini, the v-shaped notches each extending inward toward a center of the wound dressing, the notches extending through the entire thickness of the material layer, as taught by Masini. Modifying each perimeter slit of Cavanaugh to be v-shaped notches would result in at least four v-shaped notches in the perimeter of Cavanaugh/Masini. Masini indicates that the v-shaped notches improve the flexibility of the dressing, and therefore one of ordinary skill in the art would find it obvious to substitute linear notches for v-shaped notches, as v-shaped notches are shown by Masini to be known in the art for improving the flexibility of wound dressings on non-planar patient surfaces or in the event of a curved wound or incision (as motivated by Masini Col. 6 lines 34-56).
Claims 120, 122, and 123 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Cavanaugh et al (US 2009/0299342) in view of Masini (US 6599262) further in view of Rogers et al (US 2009/0177135).
Regarding Claims 120, 122, and 123, Cavanaugh/Masini is silent whether a central portion between the first notch and the second notch joins the first portion and the second portion, the central portion having a narrower width than a greatest width of the first portion and a greatest width of the second portion, and wherein the greatest width of the first portion is at least as wide as the greatest width of the second portion, wherein a width of the material layer between the side surfaces of the first portion decreases in a longitudinal direction away from the port toward the second portion, and wherein a width of the material layer between side surfaces of the second portion increases in a longitudinal direction away from the first portion.
Rogers teaches a wound dressing, thus being in the same field of endeavor, for application to the sacral region of a patient, with a symmetrical lobed shape as seen in Fig. 2. This shape allows the dressing to better adhere to the sacral region of the patient (¶ [0012]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the shape of the material layer of Cavanaugh/Masini to be the symmetrical lobed shape of Rogers. This shape allows the dressing to better adhere to the sacral region of the patient (as motivated by Rogers ¶ [0012]). This combination of Cavanaugh/Masini/Rogers would have a central portion between the first notch and the second notch that joins the first portion and the second portion, the central portion having a narrower width than a greatest width of the first portion and a greatest width of the second portion, and wherein the greatest width of the first portion is at least as wide as the greatest width of the second portion, wherein a width of the material layer between the side surfaces of the first portion decreases in a longitudinal direction away from the port toward the second portion, and wherein a width of the material layer between side surfaces of the second portion increases in a longitudinal direction away from the first portion.
Claim 125 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Cavanaugh et al (US 2009/0299342) in view of Masini (US 6599262) further in view of Locke et al (US 2013/0035649).
Regarding Claim 125, Cavanaugh/Masini is silent whether the at least one notch comprises a circular cut-out located on one of the central longitudinal axis or the transverse axis.
Locke teaches a wound dressing, thus being in the same field of endeavor, with a material layer (bolster 224, Fig. 3A) with a circular cut-out (264, Fig. 3A) located on the central longitudinal axis (as seen in Fig. 3A). This allows for easy passage of a subcutaneous delivery conduit through the bolster (¶ [0056]).
Therefore, it would have been obvious to modify the material layer of Cavanaugh/Masini to have the at least one notch comprise a circular cut-out located on one of the central longitudinal axis or the transverse axis, as taught by Locke. This allows for easy passage of a subcutaneous delivery conduit through the material layer (as motivated by Locke ¶ [0056]).
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 Jessica Arble whose telephone number is (571)272-0544. The examiner can normally be reached Mon - Fri 9 AM - 5 PM.
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/JESSICA ARBLE/ Primary Examiner, Art Unit 3781
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