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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/13/2026 has been entered.
Response to Arguments
Applicant's arguments filed 03/13/2026 have been fully considered but they are not persuasive. Applicant repeats the argument that the layer 12 in Gogolowski is not an absorbent layer. Applicant argues the layer 12 would be more akin to the top film of claim 1. Applicant argues that Gogolowski discloses an entirely different absorbent layer 40, adjacent to the layer 12, that does not include the required incisions of claim 1. Applicant argues the absorbent 40 does not include the required incisions of claim 1. Applicant argues Gogolowski explicitly describes the layer 40 as an absorbent layer such that Gogolowski also fails to disclose ,”a plurality of incisions extending at least partially through the absorbent layer and configured as a series of concentric circle such that the absorbent layer flexes in multiple directions”, since the incisions 16 in Gogolowski are not formed in absorbent layer 40. Applicant’s arguments are not persuasive. Gogolowski teaches the additional layer 40 can act as a pad layer, and can formed from open work, porous, natural or synthetic fibrous material, such as material used to form gauze, can contact the skin surface and/or wound to absorb wound exudate or excretions (Gogolowski para. 0092). Gogolowski also teaches layer 40 can used as a backing layer, where it is highly flexible and deformable (Gogolowski para. 0093). As previously stated by the examiner, Gogolowski teaches in certain embodiments, the additional layer 40 comprises material free regions 16 and/or the pattern of concentric annuli 18, of the present invention (paragraph 0091). Furthermore, Gogolowski teaches the layer 40 may incorporate the material free regions (incisions) 16 aligned with the pattern units of the layer of material 12 (Gogolowski paragraph 0091). Thus, if layer material 12 or even if the additional layer 40 is considered the absorbent of the claimed invention, the absorbent would still comprise a series of discontinuous concentric circles extending at least partially through the absorbent layer.
Applicant repeats the argument that it would not be obvious to modify the absorbent layer of Nielsen to include incisions in concentric circles. As noted above, Gogolowski teaches away from this combination in that it discloses providing the incisions in the layer 12 and leaving the absorbent layer 40 incision free. Indeed, given the openings formed in the layer 12, keeping the absorbent layer 40 incision free encourages absorption. It is well established, that the "prior art reference must be considered in its entirety, i.e., as a whole, including portions that would lead away from the claimed invention." M.P.E.P. $2141.02 VI quoting W.L. Gore & Assoc., Inc. V. Garlock, Inc., 721 F.2d 1540, 220 USPQ 303 (Fed. Cir. 1983), cert. denied, 469 U.S. 851 (1984).
Applicant’s arguments are not persuasive because Gogolowski does not teach away from this combination for the reasons provided. In fact, Gogolowski teaches the pad layer 40 comprises material free regions 16 and/or the pattern of concentric annuli 18, of the present invention (paragraph 0091). Furthermore, Gogolowski teaches the layer 40 may incorporate the material free regions (incisions) 16 aligned with the pattern units of the layer of material 12 (Gogolowski paragraph 0091).
Applicant argues the Examiner argues that the layer 12 (of Gogolowski) may include cellulose fibers and therefore the layer is absorbent. As previously explained, the layer 12 is generally applied directly to a wound and includes adhesive to hold it in place, which would inhibit absorption. The open areas 16 do not and cannot absorb exudate. The areas between the open areas in layer 12 include adhesive. Specifically, the adhesive may be water soluble, which would inhibit absorption of exudate through these sections. Thus, the bandage would not adhere to user such that the combination suggested by the Examiner would render the bandage of Gogolowski inoperable for its intended use such that it would not have been obvious to modify the art as suggested by Examiner. The Examiner previously noted that Gogolowski discloses that the adhesive may include hydrocolloids that form gels when contacting body fluids. The Examiner argued that in such cases the hydrocolloids would aid in adhering the bandage to the user. As applicant previously explained, this reinforces Applicants' position that the layer 12 is not absorbent. The combination of the hydrocolloid and body fluid remains in contact with the wound and thus inhibits absorption and healing. Thus again, the modification suggested by the Examiner would render the bandage inoperable for its intended purpose such that the modification suggested by the Examiner would not have been obvious. The examiner respectfully disagrees. In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, the hydrocolloids are old and well known in the art of wound healing as absorbents that form gel-like mixtures when combined with water and can absorb fluids. Hydrocolloids create a moist environment that promotes wound healing (Nielsen para. 0005). Thus, the examiner maintains the layer 12 has absorbent properties with respect to the absorbent fibers used to form the layer and the hydrocolloid adhesive which also provides some absorbency. Gogolowski teaches when used in adhesive bandages, these hydrocolloids are combined with elastomers and/or adhesive. Preferably, the adhesive bandage should provide a humid environment but without saturation, cicatrisation, which is a situation suitable for acceleration of the healing (paragraph 0087). Thus, not only do the adhesives of Gogolowski not inhibit absorption, but provide a benefit of accelerated healing in the wound dressing. Applicant’s arguments are not persuasive and the previous rejection remains.
Applicant further argues, as was previously explained, the structure and positioning of the layer 12 precludes its use an absorbent layer as it is in direct contact with the wound, such that it does allow for draining of the wound. However, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). In this case, Gogolowski is relied on for a teaching of the concentric circles in a wound dressing. The combined teachings of the references suggests to those of ordinary skill in the art that a wound dressing absorbent layer can be configured with concentric circles for conformity and flexibility to the wound surface as taught in Gogolowski (paras. 0002 and 0006).
Applicant’s arguments are not persuasive and the rejection is maintained.
Claims 2, and 4-15 and 20 depend on claim 1 and remain rejected for the reasons discussed above. Independent claim 21 also remains rejected at least for the reasons discussed above.
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.
6. 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.
7. 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.
8. 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.
9. Claims 1, 2, 4-15 and 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Nielsen et al. US 2003/0153860 in view of Gogolowski et al. US 2018/0289555.
As to claim 1, Nielsen et al. teaches a bandage comprising:
a top film 1 (paragraphs 0054-0055);
an absorbent layer 2 having a top surface thereof adjacent to a bottom surface of the top film. Nielsen teaches the absorbent layer including at least one incision extending at least partially through the absorbent layer (paragraph 0053). Nielsen actually teaches the absorbent layer may be embossed or pre-cut in order to enhance flexibility (paragraph 0053). However, Nielsen does not teach a plurality of incisions extending at least partially through the absorbent layer and configured as a series of discontinuous concentric circles. Gogolowski teaches a dressing having a layer 12 comprising incisions/material free regions 16 that extend through the layer 12 and are configured as a series of discontinuous concentric circles (Gogolowski Figure 7; paragraphs 0002, 0059-0062). Gogolowski teaches the material free regions 16 are for the benefit of providing a conformable dressing with sufficient drapability with improved elasticity for better coverage of movable areas such as joints (Gogolowski paragraph 0006). Gogolowski teaches the concentric circles allow the dressing to flex in multiple directions – where Gogolowski teaches in order to provide the dynamic conformability benefit, the dressing is designed to be resiliently, freely expandable to a range of three dimensional configurations when one force or a plurality of forces are directed at or applied to the dressing having the pattern of concentric slitted annuli 18 (Gogolowski para. 0077). It would have been obvious to one having ordinary skill in the art at the time the invention was originally filed to modify the absorbent layer of Nielsen with such incisions for the benefits taught in Gogolowski.
Nielsen/Gogolowski teaches and a lower layer 3 (skin-facing layer) connected to a lower surface of the absorbent layer 2, the lower layer 3 including at least one opening formed therein and extending from a bottom surface thereof to a top surface thereof (Nielsen Figures 1, 3, and 6; paragraphs 0038-0041) and including an adhesive material on the bottom surface thereof (Nielsen paragraphs 0056-0057).
As to claim 2, the at least one incision extends completely through the absorbent layer - where Gogolowski teaches the incisions 16 extend completely through the layer where they are applied (Gogolowski paragraph 0059).
As to claim 3, the at least one incision 16 extends in a spiral shape (Gogolowski Figure 7; paragraphs 0059-0062).
As to claim 4, the at least one incision comprises a plurality of segments, the segments forming a plurality of concentric circles (Gogolowski Figures 3A, 3C, 6, and 7; paragraphs 0059-0062).
As to claim 5, the plurality of segments are spaced apart from adjacent segments by substantially ten degrees (Gogolowski paragraphs 0064, 0066, 0072).
As to claims 6-7, Nielsen teaches the absorbent layer comprises superabsorbent particles (SA)) and/or super absorbent fibers (SAF) (Nielsen paragraph 0048). Nielsen further teaches a suitable absorbent material includes polyacrylate, CMC (carboxymethyl cellulose), cellulose or derivatives thereof, or alginate (Nielsen paragraph 0046). Gogolowski teaches a hydrocolloid element includes materials such as sodium carboxymethyl cellulose and alginates (paragraph 0087).
As to claims 8 and 12, Nielsen/Gogolowski teaches various materials for the absorbent layer including superabsorbent polymer and foam materials (Nielsen paragraphs 0044-0049, 0077). It would have been obvious to one having ordinary skill in the art at the time the invention was originally filed to provide the claimed first material as a super absorbent polymer and the second material as a hydrophilic polyurethane foam since it is obvious to try to combine the elements choosing from a finite number of predictable solutions particularly since the prior art composition and the claimed composition are intended to be used in the same environment and for the same purpose.
As to claim 9, the absorbent layer comprises a super absorbent polymer (Nielsen paragraphs 0048).
As to claim 10, Nielsen teaches the absorbent layer comprises:
a first layer 2 of a first material 2;
a second layer 5 of a second material (Nielsen paragraphs 0043, 0044, 0077).
As to claim 11, at least one of the first material and the second material comprises hydrophilic foam (Nielsen paragraph 0046).
As to claims 13-15, Nielsen/Gogolowski does not specifically teach the claimed depth of the incision through the absorbent layers. However, Gogolowski teaches the incision extends through the thickness 14 of at least a portion of the layer of the material 12 (Gogolowski paragraph 0044), which allows some tolerance for the incision to extend at least partially though the materials. Thus, it would obvious to one having ordinary skill in the art to have the incisions 16 extend through the layers as claimed since Gogolowski teaches the general condition of the incisions extending partially through the layers and one can determine through routine experimentation the extent of the incisions depending on the level of flexibility desired.
As to claim 20, Nielsen teaches the lower layer comprises a silicone- based adhesive on the bottom surface thereof (Nielsen paragraph 0061).
As to claim 21, Nielsen teaches a method of treating a wound comprising:
(a) providing a top film 1 (paragraphs 0054-0055);
(b) providing an absorbent layer 2 below the top film (Figures 1 and 6; paragraphs 0031, 0034, 0036);
(c) providing at least one incision in the absorbent layer (paragraph 0053); and
(d) providing a perforated lower layer below the absorbent layer (paragraph 0039).
Nielsen teaches the absorbent layer may be embossed or pre-cut in order to enhance flexibility (paragraph 0053). Nielsen does not teach a plurality of incisions extending at least partially through the absorbent layer and configured as a series of discontinuous concentric circles. Gogolowski teaches a dressing having a layer 12 comprising incisions/material free regions 16 that extend through the layer and have a spiral shape (Gogolowski Figure 7; paragraphs 0002, 0059-0062). Gogolowski teaches the material free regions 16 are for the benefit of providing a conformable dressing with sufficient drapability with improved elasticity for better coverage of movable areas such as joint (Gogolowski paragraph 0006). Gogolowski teaches the concentric circles allow the dressing to flex in multiple directions – where Gogolowski teaches in order to provide the dynamic conformability benefit, the dressing is designed to be resiliently, freely expandable to a range of three dimensional configurations when one force or a plurality of forces are directed at or applied to the dressing having the pattern of concentric slitted annuli 18 (Gogolowski para. 0077). It would have been obvious to one having ordinary skill in the art at the time the invention was originally filed to modify Nielsen with such incisions for the benefits taught in Gogolowski.
Allowable Subject Matter
10. Claims 16-19 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten to overcome the objections of claim 16 above, and if rewritten in independent form including all of the limitations of the base claim and any intervening claims. The following is a statement of reasons for the indication of allowable subject matter: With respect to claims 16-19, Nielsen specifically teaches away from an adhesive between the top film layer and absorbent layer (Nielsen paragraph 0033).
Conclusion
11. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Mulligan US Patent Application Publication 2009/0012441 is cited to show a wound dressing with an adhesive agent on the perimeter of the wound dressing.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACQUELINE F STEPHENS whose telephone number is (571)272-4937. The examiner can normally be reached 8:30-5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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/JACQUELINE F STEPHENS/ Primary Examiner, Art Unit 3781
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