DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/19/2026 has been entered.
Response to Arguments
Applicant’s amendment, filed 02/19/2026, is accepted and entered.
Applicant’s arguments with respect to claim(s) 114 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Aali is now cited in combination with Cavanaugh to teach the recited claim limitations.
Applicant did not specifically argue the dependent claims.
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 126-133 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 Aali et al (US 2010/0312159).
Regarding Claim 114, 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);
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]), the at least one notch (1078, Fig. 15) configured to alter the shape of the perimeter of the material layer in the plane (¶ [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 of the perimeter to be modified based on flexion of the body).
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Image 1: Annotated Partial Fig. 15 of Cavanaugh
Cavanaugh is silent whether the at least one notch is through the entire thickness of the material layer.
Aali teaches a wound dressing, thus being in the same field of endeavor, with a material layer (wicking strip 30’’, Fig. 6A) with at least one notch (relaxation cuts 33, Fig. 6A) in the perimeter of the material layer (30’’, Fig. 6A) through the entire thickness of the material layer (as seen in Fig. 6A). These notches enhance the lateral flexibility of the dressing, allowing the dressing to bend and buckle without crimping (¶ [0090]).
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 notches in the material layer of Cavanaugh to go through the entire thickness of the material layer, as taught by Aali, to enhance the lateral flexibility of the dressing, allowing the dressing to bend and buckle without crimping (as motivated by Aali ¶ [0090]).
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).
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 Aali et al (US 2010/0312159) further in view of Rogers et al (US 2009/0177135).
Regarding Claims 120, 122, and 123, Cavanaugh/Aali 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/Aali 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/Aali/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 Aali et al (US 2010/0312159) further in view of Locke et al (US 2013/0035649).
Regarding Claim 125, Cavanaugh/Aali 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/Aali 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
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/JESSICA ARBLE/ Primary Examiner, Art Unit 3781