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 .
Response to Amendment
The amendment filed 12/04/2025 has been entered. Claims 75, 79-80 have been amended. Claims 1-74 and 78 are cancelled. Claims 75-77, 79-89 remain pending in this application.
Response to Arguments
The amendments to claims 79 and 80 overcome the 112 rejections and the 112 rejections are therefore withdrawn.
Applicant's arguments, filed 12/04/2025, with respect to claim 75 have been fully considered but they are not persuasive.
Applicant argues that Hunt fails to disclose, suggest or render obvious the feature of individual through holes extending to the wound contact layer. However, as discussed in the rejection below, Hunt discloses (fig. 2) individual through holes extending to the wound contact layer, the wound contact layer being defined as lower foam layer 42 and lower wall 30.
Thus, claim 75 remains anticipated by Hunt.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 75-77, 81-83 and 87-89 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Hunt et al. (Pub. No.: US 2004/0030304 A1).
Regarding claim 75, Hunt discloses (fig. 2) a wound dressing (10) for negative pressure wound therapy (abstract), comprising:
A wound contact layer (characterized by lower wall 30 and second lower foam layer 42);
A first material layer (upper surface 28 of elastomeric envelope 38) comprising a first plurality of horizontally spaced apart windows (holes 32) extending vertically through a thickness of the first material layer (fig. 2, ¶ 0033); and
A second material layer (first lower foam layer 40) comprising a second plurality of horizontally spaced apart windows extending vertically through a thickness of the second material layer (fig. 2), individual first horizontally spaced apart windows aligned with individual second horizontally spaced apart windows (¶ 0047, fig. 2) to form individual through holes extending to the wound contact layer (see holes extend to second lower foam layer 42).
Regarding claim 76, Hunt discloses a cover layer (drape 14) configured to seal a wound (¶ 0039).
Regarding claim 77, Hunt discloses an absorbent layer (upper foam layer 12, ¶ 0030).
Regarding claim 81, Hunt disclose wherein the second material layer is positioned beneath the first material layer (fig. 2).
Regarding claim 82, Hunt discloses wherein the first plurality of horizontally spaced apart windows comprise a regularly spaced pattern (¶ 0016).
Regarding claim 83, Hunt discloses wherein the second plurality of horizontally spaced apart windows comprise a regularly spaced pattern (¶ 0016).
Regarding claim 87, the specification discloses that “the one or more holes can be configured to prevent or minimize blisters to the tissue by having a limited diameter. The limited diameter can be less than or equal to approximately 10 mm.” (¶ 0007). Hunt discloses that the individual windows of the first plurality of horizontally spaced windows have a length of 5 mm (¶ 0016). Thus, the feature of “wherein individual windows of the first plurality of horizontally spaced windows are configured to prevent or minimize suction blisters” is inherent to the individual windows of the first plurality of horizontally of Hunt.
It is further noted: “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). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d 775,227 USPQ 773 (Fed. Cir. 1985)”.
Further, the limitation “wherein individual windows of the first plurality of horizontally spaced windows are configured to prevent or minimize suction blisters” relates to a function of the individual windows of the first plurality of horizontally spaced windows. Since the device of Hunt is identical to the device as claimed, it must necessarily function in the identical manner.
Features of an apparatus may be recited either structurally or functionally. In re Schreiber, 128 F.3d 1473, 1478, 44 USPQ2d 1429, 1432 (Fed. Cir. 1997). See also MPEP § 2173.05(g). If an examiner concludes that a functional limitation is an inherent characteristic of the prior art, then to establish a prima case of anticipation or obviousness, the examiner should explain that the prior art structure inherently possesses the functionally defined limitations of the claimed apparatus. In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1432.
Regarding claim 88, Hunt discloses wherein the individual windows of the first plurality of horizontally spaced-apart windows are spaced apart by 10 to 40 mil (¶ 0016) or 0.254 to 1.016 mm which falls within the claimed range of 10 mm or less.
“[W]hen, as by a recitation of ranges or otherwise, a claim covers several compositions, the claim is ‘anticipated’ if one of them is in the prior art." Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (see MPEP §2131.03.I).
Regarding claim 89, Hunt discloses wherein the individual windows of the second plurality of horizontally spaced-apart windows are spaced apart by 10 to 40 mil (¶ 0016) or 0.254 to 1.016 mm which falls within the claimed range of 10 mm or less.
“[W]hen, as by a recitation of ranges or otherwise, a claim covers several compositions, the claim is ‘anticipated’ if one of them is in the prior art." Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (see MPEP §2131.03.I).
Claim Rejections - 35 USC § 103
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.
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.
Claim(s) 84 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hunt and further in view of Karami et al. (US Pat. No: 5,167,613).
Regarding claim 84, Hunt discloses (fig. 1) a wound dressing (10) for negative pressure wound therapy (abstract), comprising:
A first material layer (lower surface 30 of elastomeric envelope 38) comprising a first plurality of horizontally spaced apart windows (holes 34) extending vertically through a thickness of the first material layer (fig. 1, ¶ 0033); and
A second material layer (lower foam layer 36) comprising a second plurality of horizontally spaced apart windows extending vertically through a thickness of the second material layer (fig. 1), individual first horizontally spaced apart windows aligned with individual second horizontally spaced apart windows (fig. 1).
Hunt fails to disclose wherein individual windows of the first plurality of horizontally spaced windows are larger in dimension than individual windows of the second plurality of horizontally spaced windows.
Karami teaches (fig. 2, 5) a wound dressing (10) and thus in the same field of endeavor, comprising a first material layer (pressure-sensitive adhesive layer 14) comprising a first plurality of horizontally spaced apart windows (non-adhesive areas 16) extending vertically through a thickness of the first material layer (fig. 5); and a second material layer (sheet material 12) comprising a second plurality of horizontally spaced apart windows (slits 18) extending vertically through a thickness of the second material layer (fig. 5), individual first horizontally spaced apart windows aligned with individual second horizontally spaced apart windows (fig. 5), wherein individual windows of the first plurality of horizontally spaced windows are larger in dimension than individual windows of the second plurality of horizontally spaced windows (fig. 5).
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 individual windows of the first and second plurality of horizontally spaced windows of Hunt such that the first plurality of horizontally spaced windows are larger in dimension than the second plurality of horizontally spaced windows, as taught by Karami, in order to provide a second plurality of horizontally spaced apart windows that permit the dressing to maintain a moist environment promoting wound healing while at the same time preventing reflux or back diffusion of exudate back in to the wound (Karam col. 7, ln. 49-53).
Claim(s) 85 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hunt, as applied to claim 75 above, and further in view of Locke et al. (Pub. No.: US 2015/0320602 A1).
Regarding claim 85, Hunt fails to disclose wherein the individual windows of the first plurality of horizontally spaced windows are hexagonal in shape.
Locke teaches (fig. 1-2) a wound dressing (104) for negative pressure wound therapy (¶ 0030) and thus in the same field of endeavor, comprising a first material layer (contracting layer 114) comprising a first plurality of spaced apart windows (holes 128) extending vertically through a thickness of the first material layer (¶ 0059), wherein the individual windows of the first plurality of horizontally spaced windows are hexagonal in shape (fig. 2, ¶ 0059).
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 individual windows of the first plurality of horizontally spaced windows of Hunt such that they are hexagonal in shape, as taught by Locke, as such shape can provide a collapsing function to close a wound (Locke, ¶ 0005).
Claim(s) 86 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hunt, as applied to claim 75 above, and further in view of Greener et al. (Pub. No.: US 2010/0179463 A1).
Regarding claim 86, Hunt fails to disclose wherein individual windows of the first plurality of horizontally spaced windows are diamond-shaped.
Greener teaches (fig. 1, 4D) a wound dressing (510) (abstract) and thus in the same field of endeavor, comprising a first material layer (absorbent layer 2, 502) comprising a first plurality of spaced apart windows (apertures 12) extending vertically through a thickness of the first material layer (fig. 1), wherein individual windows of the first plurality of horizontally spaced windows are diamond-shaped (fig. 4D, ¶ 0064).
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 individual windows of the first plurality of horizontally spaced windows of Hunt such that they are diamond-shaped, as taught by Greener, as such shape can provide visibility of the wound (Greener, ¶ 0064).
Allowable Subject Matter
Claims 79-80 are objected to as being dependent upon a rejected base claim, but would be allowable 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:
The closest prior art of record is Hunt et al. (Pub. No.: US 2004/0030304 A1) which discloses individual first horizontally spaced apart windows aligned with individual second horizontally spaced apart windows. Hunt fails to disclose, teach or suggest the individual windows of at least one of the first plurality and the second plurality windows comprises a translucent or transparent material. A person having ordinary skill in the art before the effective filing date of the claimed invention would not have found it obvious to modify at least one of the first and second plurality of windows such that it comprises a translucent or transparent material. Rather, such limitation teaches away from the windows of Hunt as the windows of Hunt provide pathways for exuded fluids. Thus, such modification to the windows of Hunt would obstruct the pathways for exuded fluids.
Similarly, Threlkeld et al. (Pub. No.: US 2011/0060296 A1) discloses a dressing having a first window, a second window and a wound contact layer, the first window comprising a transparent material (transparent window 60). However, Threlkeld fails to disclose, teach or suggest the dressing being for negative pressure wound therapy and the windows being a plurality of windows.
Greener et al. (Pub. No.: US 2010/0179463 A1) discloses a first material layer (absorbent layer 2) comprising a first plurality of windows and a second material layer (wound contact layer 3) comprising a second plurality of windows, the first windows aligned with the second windows, and a transparent upper layer (1) overlaying the first layer, thus the individual windows of the first plurality of windows comprising a transparent material. However, Greener fails to disclose an additional wound contact layer, the aligned windows form individual through holes extending to the wound contact layer. Rather, Greener discloses the second material layer as being the wound contact layer.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Hanson et al. (Pub. No.: US 2016/0193452 A1) discloses a wound dressing having a window comprising a transparent material.
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 MEAGAN NGO whose telephone number is (571)270-1586. The examiner can normally be reached M - TH 8:00 - 4:00 PT.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MEAGAN NGO/Examiner, Art Unit 3781
/JACQUELINE F STEPHENS/Primary Examiner, Art Unit 3781