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 .
In view of the amendments to the claims filed 10/01/2025 in which claim 25 was amended and claims 27 and 29 were cancelled, claims 1-25 and 30 are pending in the instant application and claims 1-24 have been withdrawn. Claims 25 and 30 are further examined on the merits herein.
Priority
The instant application claims priority to U.S. Provisional Application no. 62/796,407 filed on 01/24/2019.
Priority is given for all claims to the prior-filed U.S. Provisional Application filed on 01/24/2019.
Response to Arguments
Claim Rejections under 35 U.S.C. 103
Applicant’s arguments, see pg. 6-9, filed 10/01/2025, with respect to the rejection(s) of claim(s) 25 and 29 under 35 U.S.C. 103 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 Therefore, the rejection has been withdrawn.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 Finklestein as explained below.
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 layer 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 25 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over US/2009/0069760 A1 to Finklestein.
Regarding claim 25, Finklestein discloses a dressing for treating a tissue site with negative pressure (Fig. 7), the dressing comprising:
a debridement manifold formed from an open-cell reticulated foam (para. 0015, “the foam pad comprises a highly reticulated, open-cell polyurethane or polyether foam”; para. 0040, “tissue digester may be allowed to sit on the wound for a time that is sufficient to substantially debride the wound”; para. 0043, “Fig. 4-7 shows various embodiments of a sponge that can be used in systems and methods according to the invention”; para. 0053, “layer 706 may be impregnated with a tissue digester”; Fig. 7) and having a first part having a first density (para. 0045; Fig. 7, layer 706 as a first part inherently having a density) and a second part having a variable density (para. 0045, layers 704/702 have different pore sizes, larger pore size creates a lower bulk density and vice versa; Fig. 7, layers 704/702 as a second part), the second part overlaying and adjacent to the first (Fig. 7), the first part and the second part being a unitary body (para. 0053; Fig. 7, foam sponge 700 as a single united entity formed from layers 706/704/702);
the second part of the debridement manifold having a surface configured to be positioned adjacent a plane containing at least a portion of a surface of the tissue site (para. 0043, “Fig. 4-7 shows various embodiments of a sponge that can be used in systems and methods according to the invention”; para. 0054, layer 702 considered the portion of the sponge closest to the wound; Fig. 2-3 showing methods of using a sponge of the invention), the second part comprising a plurality of first regions and a plurality of second regions (Fig. 7, first regions may be any arbitrary section of layer 704 such as first or second opposite faces, second regions may be any arbitrary section of layer 702 such as first or second opposite faces), the plurality of second regions having a greater density than the plurality of first regions (para. 0054, “the lowest level of the sponge may be formed from the smallest pore size material”, larger pore size creates a lower bulk density and vice versa);
the first density, the density of the first regions, and the density of the second regions being different (para. 0045, pore size of the layers 706/704/702 are different; a larger pore size creates a lower bulk density and vice versa).
Regarding the limitation “in response to an application of negative pressure, the first regions being configured to draw away from the plane containing the at least a portion of the surface of the tissue site” as that the invention of Finklestein discloses substantially identical structure to the claimed prior art, the claimed results are considered to be inherent. As supported in MPEP 2112.01, “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).”
Regarding claim 30, Finklestein discloses the apparatus of claim 25; however, the prior art differs from the instantly claimed invention in that the prior art fails to explicitly disclose that the plurality of first and second regions are square-shaped.
It would have been an obvious matter of design choice to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first and second regions such that they are square in shape, since a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ47 (CCPA 1976).
Alternatively, claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Finklestein as applied above, and further in view of U.S. P.G. Pub. application no. US/2011/0178451 to Robinson.
Regarding claim 30, Finklestein discloses the apparatus of claim 25; however, the prior art differs from the instantly claimed invention in that the prior art fails to explicitly disclose that the plurality of first and second regions are square-shaped.
Robinson discloses a foam wound insert (Fig. 10, 34A) made from a plurality of first (Fig. 10-11, 404 high-density regions) and second (Fig. 10-11, 408 low-density regions) regions of differing density in different shapes (para. 0064 lines 18-24, different density regions in alternating rectangles, squares, rings, circles, checkerboard pattern).
Robinson is considered to be analogous to the instantly claimed invention in that Robinson teaches a foam wound insert for use with negative pressure wound therapy. One of ordinary skill in the art would have been motivated to modify the shape and configuration of the plurality of regions of low and high density of Finklestein to be provided in different shapes as taught by Robinson, because Robinson teaches that providing low density regions permits for a user to tear a foam wound insert directionally along the region of low density (para. 0064 lines 5-18). Providing the low- and high-density regions in differing shapes allows for a user to accommodate different types and shapes of wounds that a wound filler could be used for that would otherwise be filled with a cut or broken foam that could lose foam particles within the wound space (para. 0043 lines 4-13; para. 0065 lines 1-16; Fig. 11 tunnel type wound).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Linnae Raymond whose telephone number is (571)272-6894. The examiner can normally be reached M-F 8:00am to 4:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached on (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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/Linnae E. Raymond/Examiner, Art Unit 3781
/JESSICA ARBLE/Primary Examiner, Art Unit 3781